TARRYTOWN, N.Y., November 21, 2020 – Regeneron Prescription drugs, Inc. (NASDAQ: REGN) as we speak introduced that the antibody cocktail casirivimab and imdevimab administered collectively (previously often known as REGN-COV2 or REGEN-COV2), a remedy presently being investigated to be used in COVID-19, has acquired Emergency Use Authorization (EUA) from the U.S. Meals and Drug Administration (FDA). Casirivimab and imdevimab administered collectively are licensed for the therapy of gentle to reasonable COVID-19 in adults, in addition to in pediatric sufferers not less than 12 years of age and weighing not less than 40 kg, who’ve acquired optimistic outcomes of direct SARS-CoV-2 viral testing and are at excessive threat for progressing to extreme COVID-19 and/or hospitalization. The medical proof from Regeneron’s outpatient trial means that monoclonal antibodies akin to casirivimab and imdevimab have the best profit when given early after analysis and in sufferers who haven’t but mounted their very own immune response or who’ve excessive viral load.
The standards for ‘high-risk’ sufferers are described within the Reality Sheet for Well being Care Suppliers. Casirivimab and imdevimab usually are not licensed to be used in sufferers who’re hospitalized or require oxygen remedy on account of COVID-19, or for folks presently utilizing persistent oxygen remedy due to an underlying comorbidity who require a rise in baseline oxygen circulation charge on account of COVID-19.
“This FDA Emergency Use Authorization is a crucial step within the combat towards COVID-19, as high-risk sufferers in the USA could have entry to a promising remedy early in the midst of their an infection,” stated Leonard S. Schleifer, M.D., Ph.D., President and Chief Government Officer of Regeneron. “The science and expertise investments Regeneron has revamped three a long time positioned us to maneuver quickly to invent, research and maximize manufacturing of our antibody cocktail. Even with these unimaginable efforts, demand could exceed provide initially, making it much more vital that federal and state governments make sure the casirivimab and imdevimab antibody cocktail is distributed pretty and equitably to the sufferers most in want. Within the first quarter of 2021, we anticipate to extend out there world provide as we proceed our collaboration with Roche.”
“The casirivimab and imdevimab antibody cocktail is designed to imitate what a well-functioning immune system does by utilizing very potent antibodies to neutralize the virus,” stated George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Information from roughly 800 non-hospitalized sufferers confirmed important reductions in virus ranges inside days of receiving the mix, which have been related to considerably fewer medical visits. This profit was biggest in sufferers most in danger for poor outcomes on account of excessive viral load, ineffective immune response at baseline or pre-existing threat elements. We’re inspired that no variants immune to the cocktail have been recognized within the medical trial analyses up to now, which is in line with our preclinical findings. We’re additionally very inspired by lately introduced promising vaccine outcomes; nevertheless, there stays a must deal with sufferers who develop COVID-19, particularly as some could not have had entry to or weren’t protected by vaccination. Importantly, we proceed to advance our rigorous medical trial program evaluating the security and efficacy of the antibody cocktail for each the therapy and prevention of COVID-19, and we’ll share new outcomes as out there.”
Manufacturing of monoclonal antibodies is a fancy, time- and labor-intensive course of that requires deep experience. Using manufacturing and manufacturing platforms developed over a long time, Regeneron quickly scaled up manufacturing of casirivimab and imdevimab, starting within the early days of the pandemic with help from the Biomedical Superior Analysis and Growth Authority (BARDA), a part of the Workplace of the Assistant Secretary for Preparedness and Response on the U.S. Division of Well being and Human Providers. Regeneron now expects to have therapy doses prepared for roughly 80,000 sufferers by the top of November, roughly 200,000 sufferers by the primary week of January, and roughly 300,000 sufferers in complete by the top of January 2021.
As a part of Operation Warp Velocity, in July the U.S. authorities and Regeneron signed an settlement for this preliminary provide of the casirivimab and imdevimab antibody cocktail. The U.S. authorities will coordinate with state authorities to allocate the antibody cocktail on a weekly foundation primarily based on the variety of COVID-19 circumstances in every state. The federal government has dedicated to offering these 300,000 doses without charge to sufferers, though healthcare services could cost charges associated to administration. Regeneron will instantly start delivery doses to Amerisource Bergen, a nationwide distributor, which is able to distribute the remedy as directed by the federal government.
Below the EUA, the beneficial dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg complete) administered as a single intravenous infusion. The authorization relies on optimistic Part 2 information introduced in September and October from the primary 799 adults in an ongoing randomized, double-blind, placebo-controlled trial of non-hospitalized sufferers (“outpatients”) with COVID-19.
The FDA grants Emergency Use Authorization to medicines which will assist diagnose, deal with or stop a life-threatening illness when enough and accepted options usually are not out there. The EUA is non permanent and doesn’t take the place of a proper biologics license utility (BLA) submission assessment and approval course of. This use is permitted solely throughout the declaration that circumstances exist justifying the authorization of the emergency use, until terminated or revoked sooner. Casirivimab and imdevimab haven’t been accepted by FDA and stay investigational. Analysis of its security and efficacy is ongoing in a number of medical trials. Information from these trials will probably be used to help a future BLA submission. Well being care suppliers ought to assessment the Reality Sheet for detailed info on the licensed use and necessities of the EUA and should name 844-734-6643 for extra info. Please see the Reality Sheet and FDA Letter of Authorization at
The casirivimab and imdevimab mixture remedy continues to be evaluated in Part 2/Three medical trials for the therapy of COVID-19 in sure hospitalized and non-hospitalized sufferers, the Part Three open-label RECOVERY trial of hospitalized sufferers within the UK, and a Part Three trial for the prevention of COVID-19 in family contacts of contaminated people. Up to now, greater than 7,000 folks have participated in casirivimab and imdevimab medical trials.
About Regeneron Antibody Cocktail
Casirivimab and imdevimab injection is a cocktail of two monoclonal antibodies (also called REGN10933 and REGN10987, respectively) and was designed particularly to dam infectivity of SARS-CoV-2, the virus that causes COVID-19.
To develop this novel drugs, Regeneron scientists evaluated 1000’s of fully-human antibodies produced by the corporate’s VelocImmune® mice, which have been genetically modified to have a human immune system, in addition to antibodies recognized from people who’ve recovered from COVID-19. The 2 potent, virus-neutralizing antibodies that kind the cocktail bind non-competitively to the vital receptor binding area of the virus’s spike protein, which diminishes the power of mutant viruses to flee therapy and protects towards spike variants which have arisen within the human inhabitants, as detailed in Science.
The event and manufacturing of the antibody cocktail has been funded partly with federal funds from BARDA underneath OT quantity: HHSO100201700020C. Regeneron continues to extend in-house manufacturing of casirivimab and imdevimab, and the corporate has partnered with Roche to extend the worldwide provide starting in 2021. If the remedy proves secure and efficient in medical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it within the U.S. and Roche will develop, manufacture and distribute it outdoors the U.S. As soon as each corporations are at full manufacturing capability in 2021, there are anticipated to be not less than 2 million therapy doses out there yearly.
AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION
Licensed Emergency Use
Casirivimab and imdevimab injection is an investigational mixture remedy and has been licensed by FDA for the emergency use described above. Casirivimab and imdevimab injection shouldn’t be FDA accepted for any use. Security and effectiveness of casirivimab and imdevimab injection haven’t but been established for the therapy of COVID-19.
This licensed use is simply throughout the declaration that circumstances exist justifying the authorization of the emergency use underneath part 564 (b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), until the authorization is terminated or revoked sooner.
Limitations of Licensed Use
Casirivimab and imdevimab injection shouldn’t be licensed to be used in sufferers:
who’re hospitalized on account of COVID-19, OR
who require oxygen remedy on account of COVID-19, OR
who require a rise in baseline oxygen circulation charge on account of COVID-19 in these on persistent oxygen remedy on account of underlying non-COVID-19 associated comorbidity.
Good thing about therapy with casirivimab and imdevimab injection has not been noticed in sufferers hospitalized on account of COVID-19. Monoclonal antibodies, akin to casirivimab and imdevimab, could also be related to worse medical outcomes when administered to hospitalized sufferers requiring excessive circulation oxygen or mechanical air flow with COVID-19.
Definition of Excessive-Danger Sufferers
Excessive-risk is outlined as sufferers who meet not less than one of many following standards:
Have a physique mass index (BMI) ≥35
Have persistent kidney illness
Have immunosuppressive illness
Are presently receiving immunosuppressive therapy
Are ≥65 years of age
Are ≥55 years of age AND have
heart problems, OR
persistent obstructive pulmonary illness/different persistent respiratory illness.
Are 12 – 17 years of age AND have BMI ≥85th percentile for his or her age and gender primarily based on CDC growthcharts, OR
sickle cell illness, OR
congenital or acquired coronary heart illness, OR
neurodevelopmental issues, for instance, cerebral palsy, OR
a medical-related technological dependence, for instance, tracheostomy, gastrostomy, or optimistic stress air flow (not associated to COVID-19), OR
bronchial asthma, reactive airway or different persistent respiratory illness that requires each day medicine for management.
Warnings and Precautions:
Hypersensitivity Together with Anaphylaxis and Infusion-Associated Reactions: There’s a potential for severe hypersensitivity response, together with anaphylaxis, with administration of casirivimab and imdevimab injection. If indicators or signs of a clinically important hypersensitivity response or anaphylaxis happen, instantly discontinue administration and provoke acceptable medicines and/or supportive remedy. Infusion-related reactions have been noticed with administration of casirivimab and imdevimab injection. Indicators and signs of infusion associated reactions could embody fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash together with urticaria, pruritus, myalgia, and/or dizziness. If an infusion-related response happens, take into account slowing or stopping the infusion and administer acceptable medicines and/or supportive care.
Limitations of Profit and Potential for Danger in Sufferers with Extreme COVID-19: Good thing about therapy with casirivimab and imdevimab injection has not been noticed in sufferers hospitalized on account of COVID-19. Monoclonal antibodies, akin to casirivimab and imdevimab, could also be related to worse medical outcomes when administered to hospitalized sufferers requiring excessive circulation oxygen or mechanical air flow with COVID-19. Subsequently, casirivimab and imdevimab injection shouldn’t be licensed to be used in who’re hospitalized on account of COVID-19, OR who require oxygen remedy on account of COVID-19, OR who require a rise in baseline oxygen circulation charge on account of COVID-19 in these on persistent oxygen remedy on account of underlying non-COVID-19 associated comorbidity.
Critical hostile occasions (SAEs) have been reported in 4 (1.6%) sufferers within the casirivimab and imdevimab injection 2,400 mg group, 2 (0.8%) sufferers in casirivimab and imdevimab injection 8,000 mg group and 6 (2.3%) sufferers within the placebo group. Not one of the SAEs have been thought of to be associated to review drug. SAEs that have been reported as Grade Three or Four hostile occasions have been pneumonia, hyperglycemia, nausea and vomiting (2,400 mg casirivimab and imdevimab injection), intestinal obstruction and dyspnea (8,000 mg casirivimab and imdevimab injection) and COVID-19, pneumonia and hypoxia (placebo). Casirivimab and imdevimab injection usually are not licensed on the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg imdevimab).
Affected person Monitoring Suggestions: Clinically monitor sufferers throughout infusion and observe sufferers for not less than 1 hour after infusion is full.
Use in Particular Populations:
Being pregnant: There’s presently restricted medical expertise in using casirivimab and imdevimab injection in COVID-19 sufferers who’re pregnant. Casirivimab and imdevimab injection remedy needs to be used throughout being pregnant provided that the potential profit justifies the potential threat for the mom and the fetus.
Nursing Moms: There’s presently no medical expertise in use of casirivimab and imdevimab injection in COVID-19 sufferers who’re breastfeeding. The event and well being advantages of breastfeeding needs to be thought of together with the mom’s medical want for casirivimab and imdevimab injection and any potential hostile results on the breastfed youngster from casirivimab and imdevimab injection or from the underlying maternal situation.
Regeneron (NASDAQ: REGN) is a number one biotechnology firm that invents life-transforming medicines for folks with severe illnesses. Based and led for over 30 years by physician-scientists, our distinctive potential to repeatedly and persistently translate science into drugs has led to eight FDA-approved remedies and quite a few product candidates in improvement, all of which have been homegrown in our laboratories. Our medicines and pipeline are designed to assist sufferers with eye illnesses, allergic and inflammatory illnesses, most cancers, cardiovascular and metabolic illnesses, ache, infectious illnesses and uncommon illnesses.
Regeneron is accelerating and enhancing the standard drug improvement course of by our proprietary VelociSuite® applied sciences, akin to VelocImmune, which makes use of distinctive genetically-humanized mice to supply optimized fully-human antibodies and bispecific antibodies, and thru formidable analysis initiatives such because the Regeneron Genetics Heart, which is conducting one of many largest genetics sequencing efforts on the planet.
For added details about the corporate, please go to or comply with @Regeneron on Twitter.
Ahead-Trying Statements and Use of Digital Media
This press launch contains forward-looking statements that contain dangers and uncertainties referring to future occasions and the long run efficiency of Regeneron Prescription drugs, Inc. (“Regeneron” or the “Firm”), and precise occasions or outcomes could differ materially from these forward-looking statements. Phrases akin to “anticipate,” “anticipate,” “intend,” “plan,” “consider,” “search,” “estimate,” variations of such phrases, and related expressions are supposed to establish such forward-looking statements, though not all forward-looking statements include these figuring out phrases. These statements concern, and these dangers and uncertainties embody, amongst others, the impression of SARS-CoV-2 (the virus that has induced the COVID-19 pandemic) on Regeneron’s enterprise and its workers, collaborators, and suppliers and different third events on which Regeneron depends, Regeneron’s and its collaborators’ potential to proceed to conduct analysis and medical packages (together with these mentioned on this press launch), Regeneron’s potential to handle its provide chain, web product gross sales of merchandise marketed or in any other case commercialized by Regeneron and/or its collaborators (collectively, “Regeneron’s Merchandise”), and the worldwide economic system; the character, timing, and potential success and therapeutic purposes of Regeneron’s Merchandise and product candidates and analysis and medical packages now underway or deliberate, together with with out limitation the event program referring to casirivimab and imdevimab (Regeneron’s investigational multi-antibody remedy for the therapy and prevention of COVID-19); how lengthy the Emergency Use Authorization (“EUA”) granted by the U.S. Meals and Drug Administration (the “FDA”) for casirivimab and imdevimab will stay in impact and whether or not the EUA is revoked by the FDA primarily based on its willpower that the underlying well being emergency not exists or warrants such authorization or different causes; the probability, timing, and scope of potential regulatory approval and industrial launch of Regeneron’s product candidates (akin to casirivimab and imdevimab) and new indications for Regeneron’s Merchandise; issues of safety ensuing from the administration of Regeneron’s Merchandise and product candidates (akin to casirivimab and imdevimab) in sufferers, together with severe issues or unwanted side effects in reference to using Regeneron’s Merchandise and product candidates in medical trials (together with these mentioned on this press launch); the power of Regeneron to fabricate in anticipated portions Regeneron’s Merchandise and product candidates, together with casirivimab and imdevimab; the power of Regeneron to handle provide chains for a number of merchandise and product candidates; the power of Regeneron’s collaborators, suppliers, or different third events (as relevant) to carry out manufacturing, filling, ending, packaging, labeling, distribution, and different steps associated to Regeneron’s Merchandise and product candidates; uncertainty of market acceptance and industrial success of Regeneron’s Merchandise and product candidates and the impression of research (whether or not carried out by Regeneron or others and whether or not mandated or voluntary), together with the trials mentioned on this press launch, on any potential regulatory approval (together with with respect to casirivimab and imdevimab) and/or the industrial success of Regeneron’s Merchandise and product candidates; determinations by regulatory and administrative governmental authorities which can delay or prohibit Regeneron’s potential to proceed to develop or commercialize Regeneron’s Merchandise and product candidates, together with with out limitation casirivimab and imdevimab; ongoing regulatory obligations and oversight impacting Regeneron’s Merchandise, analysis and medical packages, and enterprise, together with these referring to affected person privateness; the provision and extent of reimbursement of Regeneron’s Merchandise from third-party payers, together with non-public payer healthcare and insurance coverage packages, well being upkeep organizations, pharmacy profit administration corporations, and authorities packages akin to Medicare and Medicaid; protection and reimbursement determinations by such payers and new insurance policies and procedures adopted by such payers; competing medicine and product candidates that could be superior to, or more economical than, Regeneron’s Merchandise and product candidates; the extent to which the outcomes from the analysis and improvement packages carried out by Regeneron and/or its collaborators could also be replicated in different research and/or result in development of product candidates to medical trials, therapeutic purposes, or regulatory approval; unanticipated bills; the prices of growing, producing, and promoting merchandise; the power of Regeneron to satisfy any of its monetary projections or steering and modifications to the assumptions underlying these projections or steering; the potential for any license, collaboration, or provide settlement, together with Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated corporations, as relevant), in addition to Regeneron’s collaboration with Roche referring to casirivimab and imdevimab, to be cancelled or terminated; and dangers related to mental property of different events and pending or future litigation relating thereto (together with with out limitation the patent litigation and different associated proceedings referring to EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), and Praluent® (alirocumab)), different litigation and different proceedings and authorities investigations referring to the Firm and/or its operations, the last word final result of any such proceedings and investigations, and the impression any of the foregoing could have on Regeneron’s enterprise, prospects, working outcomes, and monetary situation. A extra full description of those and different materials dangers might be present in Regeneron’s filings with the U.S. Securities and Trade Fee, together with its Type 10-Ok for the yr ended December 31, 2019 and its Type 10-Q for the quarterly interval ended September 30, 2020. Any forward-looking statements are made primarily based on administration’s present beliefs and judgment, and the reader is cautioned to not depend on any forward-looking statements made by Regeneron. Regeneron doesn’t undertake any obligation to replace (publicly or in any other case) any forward-looking assertion, together with with out limitation any monetary projection or steering, whether or not on account of new info, future occasions, or in any other case.
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Posted: November 2020
REGN-COV2 (casirivimab and imdevimab) FDA Approval Historical past