REGENERON SEEKING EARLY USE AUTHORIZATION FOR COVID-19 ANTIBODY THERAPY
Another potential treatment option for SARS-CoV-2
Regeneron (NASDAQ: REGN) is excited about the promising clinical trial research results it is achieving with its COVID-19 antibody treatment candidate REGEN-COV2. They are having conversations with the U.S. Food and Drug Administration (FDA) about receiving Emergency Use Authorization (EUA) clearance for REGEN-COV2 to accelerate the product’s availability to the marketplace.
Initial patient care performance of REGEN-COV2 is good
REGEN-COV2 is currently progressing in several clinical trials. Regeneron reports that 524 patients enrolled in a randomized, double-blind trial of the therapy experienced significantly reduced viral load and patient/physician care requirements.
These results were further reinforced with data from a separate batch of 275 patients participating in the trial in which the antibody therapy reduced Covid-19 related physician appointment visits by 57% up to Day 29 of the treatment.
Regeneron has multiple REGEN-COV2 clinical trials underway
More than 2,000 people have been enrolled in the overall REGEN-COV2 development program that encompasses four ongoing late-stage clinical trials:
- Two Phase 2 & 3 trials for the treatment of hospitalized and non-hospitalized (“ambulatory”) COVID-19 patients
- The open-label, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK
- A Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high risk of exposure to a COVID-19 patient (such as another person living in the research subject’s immediate household)
The Phase 3 prevention trial is being conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The safety of REGEN-COV2 is being further evaluated in a Phase 1 healthy volunteer study.
REGN-COV2 is a genetically-engineered therapy
Earlier in the year Regeneron produced a selection of virus-neutralizing antibodies in their COVID-19 treatment research and identified two high potential antibodies, REGN10933 and REGN10987, that they combined to form REGEN-COV2. More testing and data analysis indicated its substantial activity against COVID-19 which warranted that REGEN-COV2 be further explored.
Thus far its progress has been optimistically positive and Regeneron continues to assertively support its clinical and commercial development phases leading up to their FDA request for emergency use authorization. Regeneron has produced enough doses for about 50,000 patients now and expects to be able to provide enough units to care for approximately 300,000 patients in total.
They are working with Swiss-based Roche to increase the production of REGN-COV2 for U.S. and worldwide markets. Roche would have commercial marketing and sales rights to REGEN-COV2 in markets outside of the United States. A global healthcare heavy hitter, Roche is already in the thick of the action in the battle against COVID-19 and has substantial initiatives underway in its pharmaceutical and diagnostic business units.
Regeneron is on a roll in 2020
Founded in 1988, Regeneron Pharmaceuticals has proven itself to be an impressive innovator and respected competitor in the biotech and pharmaceutical business sectors. REGEN-COV2 is not the first time Regeneron has combined antibodies to form a single treatment therapy.
Just recently their triple monoclonal antibody (mAb) therapy, Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) was approved by the FDA for the treatment of Zaire ebolavirus (Ebola virus) in adult and pediatric patients (including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection).
In 2019 Tarrytown, New York-based Regeneron produced over $7.8 billion in revenue driven by a 17% increase in sales. Employing over 7,000 staff members, Regeneron’s success moving forward with REGN-COV2 is highly anticipated by patients, medical professionals, governments and investors.
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