WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) said Friday that European Commission has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union and other countries.
The approval follows positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients 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.
The EC approval is based on two positive Phase 3 trials involving more than 6,000 individuals that evaluated the efficacy and safety of the antibody cocktail to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts).
Regeneron invented the antibody cocktail and is collaborating with Roche, who is primarily responsible for development and distribution outside the U.S. In addition to this Marketing Authorization Application, the companies intend to submit a future Type II Variation to the EMA that seeks to expand the indication to include the treatment of patients hospitalized because of COVID-19.
In October, the U.S. Food and Drug Administration accepted for priority review the first of two Biologics License Applications for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.
Emergency or temporary pandemic use authorizations are currently in place in more than 40 countries, including the U.S., India, Switzerland and Canada, and?the antibody cocktail?is?fully approved in Japan and conditionally approved in the United Kingdom and Australia.
In the U.S., REGEN-COV has not been approved by the FDA, but is currently authorized under an Emergency Use Authorization for use in certain?post-exposure prophylaxis'settings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.
Copyright RTT News/dpa-AFX
REGENERON PHARMACEUTICALS-Aktie komplett kostenlos handeln - auf Smartbroker.de