Benzinga | Nov 12, 2021 01:13PM EST

Europe Approves Regeneron - Roche's COVID-19 Antibody Cocktail

* The European Commission (EC) has approved Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) COVID-19 antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union (EU) and other countries.

* The authorization comes for people aged 12 years and older to treat non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19 and to prevent COVID-19.

* Related Link: EU Regulator Backs Regeneron-Roche's COVID-19 Drug.

* In October, the FDA accepted for priority review the first of two marketing applications for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

* The second application will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.

* Regeneron is collaborating with Roche Holdings AG (OTC:RHHBY) for the antibody cocktail.

* Price Action: REGN shares are up 0.32% at $628.62, RHHBY shares are down 0.54% at $50.11 during the market session on the last check Friday.