Back to top

Image: Bigstock

Regeneron (REGN) REGEN-COV BLA Review Extended by 3 Months

Read MoreHide Full Article

Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that the FDA has extended the review of the biologics license application (BLA) for antibody cocktail REGEN-COV (casirivimab and imdevimab) by three months.

The regulatory body extended the review due to ongoing discussions on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review.

The agency considers the submission of these additional data to be a major amendment to the BLA and has extended the target action date to Jul 13, 2022.

On a positive note, the FDA has not requested any new studies to complete its review of the current BLA at this time.

The FDA granted Emergency Use Authorization (EUA) to REGEN-COV in November 2020 for the treatment of COVID-19 in individuals at high risk for progression to severe COVID-19.

However, in January 2022, the FDA revised the authorizations for a few monoclonal antibody treatments, including Regeneron’s REGEN-COV (casirivimab and imdevimab), as data indicated that these treatments are highly unlikely to be active against the Omicron variant.  Therefore, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions.

Last year was promising for the company on the back of the solid performance of key drugs and contribution from the COVID-19 antibody cocktail, REGEN-COV.  Hence, this revision will dent sales in 2022 from this stream.

Regeneron invented the antibody cocktail and has collaborated with Roche. Roche is primarily responsible for development and distribution outside the United States, where it is known as Ronapreve.

Meanwhile, Regeneron is progressing with its next-generation antibodies that are active against the currently circulating variants of concern and has initiated a first-in-human clinical trial of one of these next-generation antibodies.

Shares of this Zacks #3 (Hold) company have gained 14.9% in the year so far against the industry’s decline of 13.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

Zacks Investment Research
Image Source: Zacks Investment Research

Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline (GSK - Free Report) recently received a jolt when the FDA determined that their investigational monoclonal antibody sotrovimab is no longer authorized for the treatment of COVID-19 given the absence of efficacy against the Omicron variant.

The regulatory body earlier amended the EUA for sotrovimab based on new data showing that it was unlikely that the sotrovimab 500 mg dose would be effective against the dominant Omicron BA.2 variant. The news was a big setback for Vir Biotechnology as the revision will impact sales. Vir Biotechnology reported collaboration revenues of $917.2 million in 2021 for the sale of sotrovimab under its 2020 partnership agreement with Glaxo.

Earlier, the FDA also revised the authorizations of Eli Lilly’s (LLY - Free Report) bamlanivimab and etesevimab (administered together) as data indicated that it highly unlikely to be active against the Omicron variant.

In February 2022, the FDA issued an EUA to Lilly’s bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. Lilly has signed an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.

The fate of antibody treatments for COVID-19 looks uncertain, with the FDA recently revoking the previously granted EUA to many of these.