TARRYTOWN, N.Y., Jan. 12, 2021 /PRNewswire/ — Regeneron Prescription drugs, Inc. (NASDAQ: REGN) at the moment introduced that the U.S. Division of Well being and Human Companies (HHS) and the Division of Protection (DOD) will buy extra provide of the casirivimab and imdevimab antibody cocktail to be used in non-hospitalized COVID-19 sufferers to fulfill the federal authorities’s Operation Warp Pace targets. The federal government has stated it’s going to present these doses for free of charge to sufferers, although healthcare services might cost charges associated to administration.
Below the brand new settlement, the federal government will buy all completed doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, as much as 1.25 million doses. Below a earlier settlement, Regeneron is already supplying doses to deal with roughly 300,000 folks, bringing the full potential buy to over 1.5 million doses.
“COVID-19 continues to sicken a whole bunch of 1000’s of Individuals day-after-day and the folks of Regeneron are dedicated to assist,” stated Leonard S. Schleifer, M.D., Ph.D., President and Chief Govt Officer of Regeneron. “Tackling the COVID-19 pandemic would require a mixture of public well being measures, vaccines and therapeutics. We’re happy to work with the U.S. authorities to produce our antibody cocktail as an necessary weapon on this battle.”
The U.S. authorities has stated it’s going to proceed to coordinate allocation of the antibody cocktail to state and territorial well being departments. Sufferers, caregivers and healthcare suppliers can discover websites with COVID-19 antibody therapies via these hyperlinks to the HHS or Nationwide Infusion Heart Affiliation locator instruments.
“Sufferers in our antibody cocktail outpatient medical trial skilled vital reductions in virus ranges and required fewer medical visits for COVID-19, suggesting the remedy can assist scale back the present burden on hospitals and healthcare methods,” stated George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Moreover, as anticipated, the virus continues to mutate, with the potential of creating resistance to anyone antibody. The Regeneron cocktail of two antibodies, every focusing on a special web site on the virus, reduces the potential of the virus turning into resistant.”
The casirivimab and imdevimab antibody cocktail continues to be evaluated in medical trials for the therapy of COVID-19 in sure hospitalized and non-hospitalized sufferers, together with the open-label RECOVERY trial of hospitalized sufferers within the UK, and a trial for the prevention of COVID-19 in family contacts of contaminated people. Thus far, practically 15,000 folks have participated in casirivimab and imdevimab medical trials.
The event and manufacturing of the antibody cocktail has been funded partly with federal funds from the Biomedical Superior Analysis and Improvement Authority (BARDA), a part of HHS, Workplace of the Assistant Secretary for Preparedness and Response, beneath OT quantity: HHSO100201700020C.
Particulars of the New Settlement
The present licensed dose for emergency use in non-hospitalized sufferers is 2,400 mg (1,200 mg casirivimab and 1,200 mg imdevimab) administered as a one-time infusion. Regeneron is evaluating the security and efficacy of a decrease 1,200 mg dose (600 mg casirivimab and 600 mg imdevimab) of the antibody cocktail on this ‘outpatient’ setting.
Below the settlement, the federal government will purchase doses on the lowest licensed dose. The federal government is obligated to buy all completed doses equipped by June 30, as much as 1.25 million doses complete (an settlement worth of as much as $2.625 billion), and will settle for doses after this date at its discretion. Numerous elements might influence out there completed provide by June 30, together with manufacturing issues and licensed dose ranges. Regeneron expects to produce roughly 750,000 completed doses by the top of June based mostly on the two,400 mg dose degree, with the overwhelming majority equipped within the second quarter. Regeneron expects to meet the complete 1.25 million focused doses if the 1,200 mg dose is allowed.
In regards to the Regeneron Antibody Cocktail for COVID-19
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (often known as REGN10933 and REGN10987, respectively) and was designed particularly to dam infectivity of SARS-CoV-2, the virus that causes COVID-19. The 2 potent, virus-neutralizing antibodies that type the cocktail bind non-competitively to the important receptor binding area of the virus’s spike protein, which diminishes the flexibility of mutant viruses to flee therapy and protects towards spike variants which have arisen within the human inhabitants, as detailed in Science.
In November 2020, the casirivimab and imdevimab antibody mixture obtained Emergency Use Authorization (EUA) from the FDA for the therapy of gentle to average COVID-19 in adults, in addition to in pediatric sufferers at the very least 12 years of age and weighing at the very least 40 kg, who’ve obtained 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 similar to casirivimab and imdevimab have the best profit when given early after prognosis and in sufferers who’re seronegative and/or who’ve excessive viral load. The standards for ‘high-risk’ sufferers are described within the Truth Sheet for Healthcare Suppliers. Within the U.S., casirivimab and imdevimab aren’t licensed to be used in sufferers who’re hospitalized because of COVID-19 or require oxygen remedy, or for folks presently utilizing persistent oxygen remedy due to an underlying comorbidity who require a rise in baseline oxygen movement fee because of COVID-19.
Regeneron is collaborating with Roche to extend international provide of casirivimab and imdevimab. Regeneron is accountable for improvement and distribution of the therapy within the U.S., and Roche is primarily accountable for improvement and distribution exterior the U.S. The businesses share a dedication to creating the antibody cocktail out there to COVID-19 sufferers across the globe and can help entry in low- and lower-middle-income nations via drug donations to be made in partnership with public well being organizations.
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 will not 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 at some point of the declaration that circumstances exist justifying the authorization of the emergency use beneath 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 will not be licensed to be used in sufferers:
who’re hospitalized because of COVID-19, OR
who require oxygen remedy because of COVID-19, OR
who require a rise in baseline oxygen movement fee because of COVID-19 in these on persistent oxygen remedy because of underlying non-COVID-19 associated comorbidity.
Advantage of therapy with casirivimab and imdevimab injection has not been noticed in sufferers hospitalized because of COVID-19. Monoclonal antibodies, similar to casirivimab and imdevimab, could also be related to worse medical outcomes when administered to hospitalized sufferers requiring excessive movement oxygen or mechanical air flow with COVID-19.
Definition of Excessive-Threat Sufferers
Excessive-risk is outlined as sufferers who meet at the very least 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 based mostly on CDC development charts, 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 every 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 vital hypersensitivity response or anaphylaxis happen, instantly discontinue administration and provoke applicable 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 might embrace fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash together with urticaria, pruritus, myalgia, and/or dizziness. If an infusion-related response happens, think about slowing or stopping the infusion and administer applicable medicines and/or supportive care.
Limitations of Profit and Potential for Threat in Sufferers with Extreme COVID-19: Advantage of therapy with casirivimab and imdevimab injection has not been noticed in sufferers hospitalized because of COVID-19. Monoclonal antibodies, similar to casirivimab and imdevimab, could also be related to worse medical outcomes when administered to hospitalized sufferers requiring excessive movement oxygen or mechanical air flow with COVID-19. Subsequently, casirivimab and imdevimab injection will not be licensed to be used in who’re hospitalized because of COVID-19, OR who require oxygen remedy because of COVID-19, OR who require a rise in baseline oxygen movement fee because of COVID-19 in these on persistent oxygen remedy because of underlying non-COVID-19 associated comorbidity.
Severe antagonistic 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-about to be associated to check drug. SAEs that have been reported as Grade Three or Four antagonistic 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 aren’t 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 at the very least 1 hour after infusion is full.
Use in Particular Populations:
Being pregnant: There may be presently restricted medical expertise in the usage of casirivimab and imdevimab injection in COVID-19 sufferers who’re pregnant. Casirivimab and imdevimab injection remedy ought to be used throughout being pregnant provided that the potential profit justifies the potential threat for the mom and the fetus.
Nursing Moms: There may be 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 ought to be thought-about together with the mom’s medical want for casirivimab and imdevimab injection and any potential antagonistic results on the breastfed little one 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 ailments. Based and led for over 30 years by physician-scientists, our distinctive capacity to repeatedly and constantly translate science into medication has led to eight FDA-approved therapies 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 ailments, allergic and inflammatory ailments, most cancers, cardiovascular and metabolic ailments, ache, infectious ailments and uncommon ailments.
Regeneron is accelerating and enhancing the standard drug improvement course of via our proprietary VelociSuite® applied sciences, similar to VelocImmune, which makes use of distinctive genetically-humanized mice to provide 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 earth.
For added details about the corporate, please go to or comply with @Regeneron on Twitter.
Ahead-Wanting Statements and Use of Digital Media
This press launch consists of forward-looking statements that contain dangers and uncertainties regarding future occasions and the longer term efficiency of Regeneron Prescription drugs, Inc. (“Regeneron” or the “Firm”), and precise occasions or outcomes might differ materially from these forward-looking statements. Phrases similar to “anticipate,” “count on,” “intend,” “plan,” “consider,” “search,” “estimate,” variations of such phrases, and comparable expressions are meant to determine such forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. These statements concern, and these dangers and uncertainties embrace, amongst others, the influence of SARS-CoV-2 (the virus that has prompted the COVID-19 pandemic) on Regeneron’s enterprise and its staff, collaborators, and suppliers and different third events on which Regeneron depends, Regeneron’s and its collaborators’ capacity to proceed to conduct analysis and medical applications (together with these mentioned on this press launch), Regeneron’s capacity to handle its provide chain, internet 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 attainable success and therapeutic functions of Regeneron’s Merchandise and product candidates and analysis and medical applications now underway or deliberate, together with with out limitation the event program regarding the casirivimab and imdevimab antibody cocktail (Regeneron’s investigational dual-antibody remedy for COVID-19); how lengthy the Emergency Use Authorization (“EUA”) granted by the U.S. Meals and Drug Administration (the “FDA”) for the casirivimab and imdevimab antibody cocktail will stay in impact and whether or not the EUA is revoked by the FDA based mostly on its willpower that the underlying well being emergency not exists or warrants such authorization or different causes; the probability, timing, and scope of attainable regulatory approval and industrial launch of Regeneron’s product candidates (such because the casirivimab and imdevimab antibody cocktail) and new indications for Regeneron’s Merchandise; the flexibility 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 (together with the casirivimab and imdevimab antibody cocktail) and the influence of the foregoing on Regeneron’s capacity to produce its Merchandise and product candidates, together with its capacity to produce doses of the casirivimab and imdevimab antibody cocktail beneath the phrases of the settlement with the U.S. Division of Well being and Human Companies and the Division of Protection (collectively, the “U.S. Authorities”) mentioned on this press launch (the “Manufacturing and Provide Settlement”); whether or not and to what extent Regeneron will be capable to provide doses of the casirivimab and imdevimab antibody cocktail beneath the Manufacturing and Provide Settlement; what the bottom licensed dose of the casirivimab and imdevimab antibody cocktail can be on the time of supply to the U.S. Authorities beneath the Manufacturing and Provide Settlement; the quantity of funds (if any) Regeneron might obtain pursuant to the Manufacturing and Provide Settlement; whether or not the Manufacturing and Provide Settlement is terminated by the U.S. Authorities or in any other case previous to completion; the flexibility of Regeneron to handle provide chains for a number of merchandise and product candidates; questions of safety ensuing from the administration of Regeneron’s Merchandise and product candidates (similar to the casirivimab and imdevimab antibody cocktail) in sufferers, together with severe problems or uncomfortable side effects in reference to the usage of Regeneron’s Merchandise and product candidates in medical trials (together with these mentioned on this press launch); uncertainty of market acceptance and industrial success of Regeneron’s Merchandise and product candidates and the influence 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 the casirivimab and imdevimab antibody cocktail) 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 capacity to proceed to develop or commercialize Regeneron’s Merchandise and product candidates, together with with out limitation the casirivimab and imdevimab antibody cocktail; ongoing regulatory obligations and oversight impacting Regeneron’s Merchandise, analysis and medical applications, and enterprise, together with these regarding affected person privateness; the supply and extent of reimbursement of Regeneron’s Merchandise from third-party payers, together with non-public payer healthcare and insurance coverage applications, well being upkeep organizations, pharmacy profit administration firms, and authorities applications similar to Medicare and Medicaid; protection and reimbursement determinations by such payers and new insurance policies and procedures adopted by such payers; competing medication and product candidates which may be superior to, or less expensive than, Regeneron’s Merchandise and product candidates; the extent to which the outcomes from the analysis and improvement applications 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 functions, or regulatory approval; unanticipated bills; the prices of creating, producing, and promoting merchandise; the flexibility of Regeneron to fulfill any of its monetary projections or steerage and adjustments to the assumptions underlying these projections or steerage; 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 firms, as relevant), in addition to Regeneron’s collaboration with Roche regarding the casirivimab and imdevimab antibody cocktail, 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 regarding EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), and Praluent® (alirocumab)), different litigation and different proceedings and authorities investigations regarding the Firm and/or its operations, the last word end result of any such proceedings and investigations, and the influence any of the foregoing might have on Regeneron’s enterprise, prospects, working outcomes, and monetary situation. A extra full description of those and different materials dangers could be present in Regeneron’s filings with the U.S. Securities and Change Fee, together with its Kind 10-Okay for the 12 months ended December 31, 2019 and its Kind 10-Q for the quarterly interval ended September 30, 2020. Any forward-looking statements are made based mostly 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 steerage, whether or not on account of new info, future occasions, or in any other case.
Regeneron makes use of its media and investor relations web site and social media shops to publish necessary details about the Firm, together with info which may be deemed materials to traders. Monetary and different details about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations web site () and its Twitter feed ().
SOURCE Regeneron Prescription drugs, Inc.
Posted: January 2021
REGN-COV2 (casirivimab and imdevimab) FDA Approval Historical past