CHMP Recommends european Approval of Regeneron Antibody Cocktail to treat and prevent COVID-19

TARRYTOWN, N.Y., Nov. 11, 2021 /PRNewswire/ -- Regeneron pharmaceuticals, Inc. (NASDAQ: REGN) today introduced that the european drugs company's (EMA) Committee for Medicinal items for Human Use (CHMP) has adopted a positive opinion for the casirivimab and imdevimab antibody cocktail, called REGEN-COV® in the U.S. and Ronapreve™ within the European Union (ecu) and different international locations. The wonderful opinion is for americans aged 12 years and older for the medication of non-hospitalized patients (outpatients) with proven COVID-19 who do not require oxygen supplementation and who're at accelerated possibility of progressing to severe COVID-19, and to avoid COVID-19. A final decision from the eu fee related to the approval of the antibody cocktail is expected in the close future.

The nice opinion is according to two fantastic section 3 trials involving more than 6,000 individuals that evaluated the efficacy and safeguard of the antibody cocktail to treat non-hospitalized sufferers already contaminated with SARS-CoV-2, and to prevent symptomatic an infection in asymptomatic family contacts of SARS-CoV-2 infected individuals (both uninfected and contaminated contacts).

Regeneron invented the antibody cocktail and is participating with Roche, who is essentially responsible for development and distribution outdoor the U.S. besides this advertising Authorization utility, the companies intend to submit a future category II variation to the EMA that seeks to expand the capabilities indication to include the remedy of patients hospitalized as a result of COVID-19.

In October, the U.S. food and Drug Administration (FDA) authorized for precedence review the primary of two Biologics License applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized sufferers and as prophylaxis in definite individuals. The second BLA submission will center of attention on those hospitalized because of COVID-19 and is anticipated to be achieved later this yr.

within the U.S., REGEN-COV has not been approved by the FDA, however is at the moment approved under an Emergency Use Authorization (EUA) for use in definite  publish-exposure prophylaxis  settings and as a medicine for non-hospitalized individuals with gentle to average COVID-19 who are at excessive chance of significant penalties from COVID-19.

Regeneron and Roche share a commitment to creating the antibody cocktail attainable around the globe and will help entry in low- and lower-center-revenue countries through drug donations to be made in partnership with public fitness corporations.

The building and manufacturing of REGEN-COV have been funded in part with federal dollars from the Biomedical superior analysis and building Authority, a part of the U.S. branch of fitness and Human features' office of the Assistant Secretary for Preparedness and Response, beneath OT quantity: HHSO100201700020C.

concerning the REGEN-COV Antibody CocktailREGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that changed into designed exceptionally to block infectivity of SARS-CoV-2, the virus that motives COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. the two robust, virus-neutralizing antibodies that kind the cocktail bind non-competitively to the vital receptor binding domain of the virus's spike protein, which diminishes the capacity of mutant viruses to break out remedy and protects towards spike variations which have arisen in the human inhabitants, as specific in phone and Science.

numerous analyses have proven that the antibody cocktail retains efficiency towards the leading editions of issue, including Delta (first identified in India), Gamma (first identified in Brazil), Beta (first identified in South Africa) and Mu (first identified in Colombia), with counsel obtainable within the reality Sheet for Healthcare providers. Regeneron will proceed actively monitoring the potency of REGEN-COV in opposition t rising editions.

REGEN-COV has no longer been approved by way of the FDA, but is presently approved for emergency use for the medication and post-publicity prophylaxis in certain high risk people. within the U.S., REGEN-COV is not licensed as a substitute for vaccination against COVID-19, or for pre-exposure prophylaxis for prevention of COVID-19, or for use in sufferers who are hospitalized as a result of COVID-19 or require oxygen therapy, or for individuals at present the usage of persistent oxygen remedy because of an underlying comorbidity who require a rise in baseline oxygen movement expense due to COVID-19. This authorization is for the duration of the statement that situations exist justifying the authorization of the emergency uses under area 564(b)(1) of the Act, 21 united statesC. § 360bbb-3(b)(1), until the authorization is terminated or revoked sooner. more information about REGEN-COV within the U.S. is under (licensed uses and signif icant protection counsel).

Emergency or transient pandemic use authorizations are currently in location in more than 40 countries, including the U.S., in a few countries within the ecu, India, Switzerland and Canada, and the antibody cocktail is totally accredited in Japan and conditionally accepted in the uk and Australia.

within the U.S., REGEN-COV is attainable for free to  eligible people as part of a U.S. executive funded software, and in September Regeneron introduced a new contract with the U.S. govt to supply an further 1.four million 1,200 mg doses of REGEN-COV with the aid of January 2022. information on the way to entry REGEN-COV all over the U.S. is obtainable from the branch of fitness and Human functions and the countrywide Infusion core association.

About Regeneron's VelocImmune TechnologyRegeneron's VelocImmune know-how makes use of a proprietary genetically engineered mouse platform endowed with a genetically humanized immune device to produce optimized utterly human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos become a graduate student along with his mentor Frederick W. Alt in 1985, they had been the first to envision making this kind of genetically humanized mouse, and Regeneron has spent decades inventing and setting up VelocImmune and linked VelociSuite technologies. Dr. Yancopoulos and his crew have used VelocImmune know-how to create about 1 / 4 of all original, FDA-accepted fully human monoclonal antibodies at present attainable. This contains REGEN–COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and In mazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).

authorized uses and critical defense counsel

medication:REGEN-COV is authorized for the remedy of gentle to average coronavirus ailment 2019 (COVID-19) in adults and pediatric sufferers (12 years of age and older weighing at the least 40 kg) with wonderful outcomes of direct SARS-CoV-2 viral trying out, and who are at high chance for progression to extreme COVID-19, together with hospitalization or loss of life

obstacles of licensed Use (remedy)

REGEN-COV isn't approved for use in sufferers:

who're hospitalized as a result of COVID-19, OR

who require oxygen therapy because of COVID-19, OR

who require an increase in baseline oxygen movement expense as a result of COVID-19 in these on persistent oxygen remedy as a result of underlying non-COVID-19 linked comorbidity

Monoclonal antibodies, akin to REGEN-COV, could be linked to worse scientific results when administered to hospitalized patients with COVID-19 requiring high-circulation oxygen or mechanical ventilation

submit-publicity Prophylaxis:REGEN-COV is authorized in grownup and pediatric individuals (12 years of age and older weighing as a minimum 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for development to extreme COVID-19, together with hospitalization or demise, and are:

now not entirely vaccinated or who are not anticipated to mount an ample immune response to comprehensive SARS-CoV-2 vaccination (for example, people with immunocompromising situations together with those taking immunosuppressive medications) and

have been exposed to an individual contaminated with SARS-CoV-2 per close contact criteria per facilities for disease manage and Prevention (CDC) or

who are at high risk of exposure to someone infected with SARS-CoV-2 as a result of incidence of SARS-CoV-2 infection in different individuals in the equal institutional surroundings (as an example, nursing homes, prisons)

limitations of approved Use (submit-publicity Prophylaxis)

put up-exposure prophylaxis with REGEN-COV isn't an alternative to vaccination in opposition t COVID-19

REGEN-COV isn't licensed for pre-exposure prophylaxis for prevention of COVID-19

REGEN-COV has now not been permitted, however has been licensed for emergency use through FDA

These makes use of are approved best throughout the declaration that situations exist justifying the authorization of the emergency use below part 564(b)(1) of the Act, 21 u.s.a.C. § 360bbb-three(b)(1), unless the authorization is terminated or revoked sooner

Healthcare suppliers should overview the truth Sheet for Healthcare suppliers for assistance on the approved uses of REGEN-COV and necessary requirements of the EUA and need to conform to the necessities of the EUA. The FDA Letter of Authorization is purchasable for reference, as neatly because the expensive Healthcare company Letter and patient fact Sheet

criteria for determining high chance individuals

Please consult with the reality Sheet for Healthcare providers for standards for choosing high possibility individuals

SARS-CoV-2 Viral variants

Circulating SARS-CoV-2 viral variants could be linked to resistance to monoclonal antibodies. Healthcare providers may still review the Antiviral Resistance suggestions in part 15 of the truth Sheet for details regarding specific variants and resistance, and discuss with the CDC website ( https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-instances.html ) in addition to suggestions from state and local health authorities involving reports of viral variations of significance of their area to e book remedy selections

critical protection information

REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited medical data available. critical and sudden adversarial pursuits may additionally occur that have not been up to now pronounced with REGEN-COV use

Contraindication:REGEN-COV is contraindicated in people with old severe hypersensitivity reactions, together with anaphylaxis, to REGEN-COV

Warnings and Precautions:

Hypersensitivity including Anaphylaxis and Infusion-linked Reactions: critical hypersensitivity reactions, including anaphylaxis, were accompanied with administration of REGEN-COV. If signals or signs of a clinically massive hypersensitivity response or anaphylaxis ensue, automatically discontinue administration and initiate applicable drugs and/or supportive remedy. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with using REGEN-COV beneath EUA. Infusion-linked reactions, taking place throughout the infusion and up to 24 hours after the infusion, have been accompanied with administration of REGEN-COV. These reactions can be severe or lifestyles threatening

signals and signs of infusion-connected reactions may additionally include: fever, difficulty respiration, decreased oxygen saturation, chills, nausea, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest ache or pain, weak spot, altered mental repute, headache, bronchospasm, hypotension, hypertension, angioedema, throat infection, rash together with urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness, fatigue and diaphoresis. consider slowing or stopping the infusion and administer acceptable medications and/or supportive care if an infusion-connected reaction occurs

medical Worsening After REGEN-COV Administration: clinical worsening of COVID-19 after administration of REGEN-COV has been stated and might include indications or symptoms of fever, hypoxia or elevated respiratory problem, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental fame. Some of these movements required hospitalization. It is not primary if these movements were concerning REGEN-COV use or have been as a result of development of COVID-19

barriers of benefit and advantage for chance in sufferers with extreme COVID-19: Monoclonal antibodies, akin to REGEN-COV, may well be linked to worse scientific results when administered to hospitalized sufferers with COVID-19 requiring high-movement oxygen or mechanical air flow. for this reason, REGEN-COV isn't licensed for use in sufferers who're hospitalized as a result of COVID-19, OR who require oxygen therapy as a result of COVID-19, OR who require an increase in baseline oxygen flow fee because of COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–linked comorbidity

opposed Reactions:

COV-2067 (medicine): Infusion-related reactions (opposed event assessed as causally connected with the aid of the investigator) of grade 2 or greater severity were observed in 10/4,206 (0.2%) of those that bought REGEN-COV on the authorized dose or a higher dose. Three topics receiving the 8,000 mg dose of REGEN-COV, and one field receiving the 1,200 mg casirivimab and 1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting, rash) which resulted in everlasting discontinuation of the infusion. All activities resolved. Anaphylactic reactions have been suggested within the clinical software in subjects receiving REGEN-COV. The hobbies started within 1 hour crowning glory of the infusion, and in at least one case required medicine together with epinephrine. The routine resolved

COV-2069 (submit-exposure prophylaxis): In topics who have been SARS-CoV-2 negative at baseline (Cohort A), injection web site reactions (all grade 1 and 2) befell in 55 topics (four%) within the REGEN-COV community and 19 topics (2%) in the placebo community. the most commonplace signals and indicators of injection website reactions which passed off in at the least 1% of topics in the REGEN-COV community had been erythema and pruritus. Hypersensitivity reactions happened in 2 subjects (0.2%) within the REGEN-COV group and all hypersensitivity reactions had been grade 1 in severity. In topics who have been SARS-CoV-2 advantageous at baseline (Cohort B), injection web page reactions, all of which were grade 1 or 2, befell in 6 subjects (4%) in the REGEN-COV community and 1 subject (1%) within the placebo neighborhood. the most commonplace indications and indicators of injection site reactions which occurred in at the least 1% of topics within the REGEN-COV community have been ecch ymosis and erythema

COV-2093 (Subcutaneous Dosing): Injection site reactions passed off in 12% and four% of topics following single dose administration within the REGEN-COV and placebo organizations, respectively. closing safety discovering following subcutaneous administration within the REGEN-COV group had been akin to the safeguard findings accompanied with intravenous administration in COV-2067. With repeat dosing, injection site reactions befell in 252 topics (35%) within the REGEN-COV neighborhood and 38 topics (16%) within the placebo community; all injection web page reactions were grade 1 or 2 in severity. Hypersensitivity reactions took place in eight subjects (1%) in the REGEN-COV group; and all hypersensitivity reactions were grade 1 or 2 in severity. there have been no instances of anaphylaxis

patient Monitoring recommendations: Clinically display screen sufferers all through dose administration and take a look at patients for at the least 1 hour after intravenous infusion or subcutaneous dosing is finished

Use in specific Populations:

pregnancy: There are inadequate statistics to consider a drug-associated possibility of principal birth defects, miscarriage, or hostile maternal or fetal outcomes. REGEN-COV should best be used during being pregnant if the potential benefit outweighs the potential possibility for the mother and the fetus

Lactation: There are not any obtainable information on the presence of casirivimab and/or imdevimab in human milk or animal milk, the consequences on the breastfed child, or the effects of the drug on milk creation. The building and health merits of breastfeeding should still be regarded along with the mother's clinical need for REGEN-COV and any abilities hostile effects on the breastfed child from REGEN-COV or from the underlying maternal condition

About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents lifestyles-remodeling medicines for americans with serious ailments. situated and led for over 30 years with the aid of health care provider-scientists, our enjoyable skill to repeatedly and invariably translate science into medication has ended in 9 FDA-permitted cures and a lot of product candidates in development, just about all of which were homegrown in our laboratories. Our medicines and pipeline are designed to aid sufferers with eye ailments, allergic and inflammatory diseases, melanoma, cardiovascular and metabolic diseases, ache, hematologic conditions, infectious illnesses and infrequent ailments.

Regeneron is accelerating and enhancing the average drug development technique via our proprietary VelociSuite applied sciences, akin to VelocImmune, which makes use of wonderful genetically humanized mice to produce optimized totally human antibodies and bispecific antibodies, and thru formidable research initiatives such as the Regeneron Genetics core, which is conducting one of the greatest genetics sequencing efforts on earth.

For additional information concerning the company, please discuss with www.regeneron.com or comply with @Regeneron on Twitter.

forward-searching Statements and Use of Digital MediaThis press liberate includes ahead-looking statements that contain hazards and uncertainties regarding future hobbies and the long run efficiency of Regeneron prescribed drugs, Inc. ("Regeneron" or the "business"), and precise pursuits or results may vary materially from these forward-looking statements. phrases comparable to "expect," "predict," "intend," "plan," "trust," "seek," "estimate," adaptations of such words, and an identical expressions are supposed to establish such forward-looking statements, although not all forward-searching statements comprise these deciding on phrases. These statements challenge, and these dangers and uncertainties include, amongst others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's enterprise and its personnel, collaborators, and suppliers and other third parties on which Regeneron depends, Regeneron's and its collaborators' means to continue to conduct research and clinical classes, Regeneron's means to control its supply chain, web product revenue of items marketed or otherwise commercialized via Regeneron and/or its collaborators or licensees (jointly, "Regeneron's items"), and the global economic climate; the character, timing, and feasible success and therapeutic applications of Regeneron's products and product candidates being developed with the aid of Regeneron and/or its collaborators or licensees (together, "Regeneron's Product Candidates") and analysis and medical classes now underway or deliberate, together with devoid of drawback the construction application regarding the casirivimab and imdevimab antibody cocktail known as REGEN-COV® in the u.s. and Ronapreve™ in different nations; the have an effect on of the opinion adopted through the eu drugs company's Committee for Medicinal items for Human Use ment ioned during this press release on expertise approval by way of the eu commission of REGEN-COV for the medication of non-hospitalized sufferers (outpatients) with demonstrated COVID-19 who do not require oxygen supplementation and who're at expanded possibility of progressing to extreme COVID-19, and to avoid COVID-19, and the timing of this sort of approval; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's items and Regeneron's Product Candidates (akin to REGEN-COV), together with the have an impact on of options, instructions, or reports (no matter if carried out by Regeneron or others and no matter if mandated or voluntary), such because the experiences mentioned in this press release, on any of the foregoing or any abilities regulatory approval of Regeneron's products and Regeneron's Product Candidates; the likelihood, timing, and scope of viable regulatory approval and business launch of Regeneron's Product Candidates (comparabl e to REGEN-COV, including in line with the marketing Authorization software, class II model, and Biologics License applications filed or deliberate to be filed with the european drug treatments agency and U.S. meals and Drug Administration (the "FDA"), as relevant, referenced during this press liberate) and new signals for Regeneron's products; how long the Emergency Use Authorization ("EUA") granted through the FDA for REGEN-COV will stay in impact, even if the EUA could be up-to-date to include pre-exposure prophylaxis and/or the medicine for hospitalized patients, and whether the EUA is revoked via the FDA in line with its choice that the underlying fitness emergency now not exists or warrants such authorization or different factors; competing medicine and product candidates that could be superior to, or more not pricey than, Regeneron's products and Regeneron's Product Candidates (together with one of these competing medication and product candidates that can also provide extra efficacious, more simply administered, more inexpensive, or in any other case advanced medication or prophylaxis for COVID-19); the capacity of Regeneron's collaborators, licensees, suppliers, or other third parties (as relevant) to operate manufacturing, filling, completing, packaging, labeling, distribution, and other steps related to Regeneron's items and Regeneron's Product Candidates (together with REGEN-COV) and the impact of the foregoing on Regeneron's capacity to give Regeneron's products and Regeneron's Product Candidates (together with REGEN-COV); the skill of Regeneron to control provide chains for dissimilar items and product candidates; defense issues because of the administration of Regeneron's products and Regeneron's Product Candidates (equivalent to REGEN-COV) in sufferers, together with severe complications or side outcomes in connection with using Regeneron's items and Regeneron's Product Candidates in medical trials; determinati ons through regulatory and administrative governmental authorities which may additionally prolong or avoid Regeneron's potential to proceed to boost or commercialize Regeneron's items and Regeneron's Product Candidates, together with without difficulty REGEN-COV; ongoing regulatory obligations and oversight impacting Regeneron's items, research and scientific classes, and business, together with those relating to patient privateness; the availability and extent of reimbursement of Regeneron's items from third-birthday celebration payers, together with inner most payer healthcare and assurance courses, fitness preservation corporations, pharmacy advantage management companies, and government programs reminiscent of Medicare and Medicaid; insurance and repayment determinations through such payers and new guidelines and approaches adopted by using such payers; the extent to which the outcomes from the analysis and building classes performed by way of Regeneron and/or its coll aborators or licensees may well be replicated in different studies and/or cause development of product candidates to clinical trials, therapeutic functions, or regulatory approval; unanticipated charges; the fees of establishing, producing, and promoting products; the ability of Regeneron to fulfill any of its fiscal projections or advice and alterations to the assumptions underlying these projections or information; the competencies for any license, collaboration, or deliver contract, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated businesses, as relevant), in addition to Regeneron's collaboration with Roche concerning the casirivimab and imdevimab antibody cocktail and its REGEN-COV give agreement with the U.S. executive, to be cancelled or terminated; and risks linked to intellectual property of alternative parties and pending or future litigation relating thereto (together with devoid of hindrance t he patent litigation and other related complaints concerning EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Praluent® (alirocumab), and REGEN-COV), other litigation and different lawsuits and govt investigations regarding the company and/or its operations, the top-rated outcome of this sort of lawsuits and investigations, and the have an effect on any of the foregoing may additionally have on Regeneron's business, prospects, operating effects, and fiscal circumstance. A extra comprehensive description of these and other material hazards will also be present in Regeneron's filings with the U.S. Securities and trade fee, including its form 10-okay for the 12 months ended December 31, 2020 and its form 10-Q for the quarterly duration ended September 30, 2021. Any ahead-looking statements are made in response to administration's existing beliefs and judgment, and the reader is cautioned no longer to depend on any forward-searching statements made through Regeneron. Rege neron doesn't undertake any obligation to replace (publicly or otherwise) any forward-looking statement, including without drawback any monetary projection or information, no matter if on account of new counsel, future events, or otherwise.

Regeneron uses its media and investor members of the family website and social media retailers to post vital information in regards to the enterprise, together with assistance that could be deemed cloth to investors. monetary and other counsel about Regeneron is mechanically posted and is purchasable on Regeneron's media and investor members of the family web page ( http://newsroom.regeneron.com ) and its Twitter feed ( http://twitter.com/regeneron ).

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