FDA Limits Use of Two Monoclonal Antibodies For COVID-19 Treatment Due to the Omicron Variant
- Wall Street ends lower as Cisco and Apple sink
- A Recession Could Push S&P 500 to 3360 - Goldman Sachs
- Palo Alto Networks Shares Surge 11% on Q3 Earnings Beat and Raise
- Twitter (TWTR) Says Musk Deal Not 'On-Hold', Won't Renegotiate Price
- After-Hours Stock Movers 05/19: Palo Alto Ramps on Strong Results; Ross Stores Plunges (more...)
News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.
The United States Food and Drug Administration (FDA) released a statement today, according to which it limits the use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant.
According to the statement, FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab from Eli Lilly and Company (NYSE: LLY) and REGEN-COV (casirivimab and imdevimab) from Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), as the most recent data show these treatments are highly unlikely to be active against the Omicron variant, which is estimated to account for more than 99% of cases in the United States as of Jan. 15.
Given that it is highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than Omicron, FDA doesn’t authorize these treatments for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then the use of these treatments may be authorized in these regions.
Several other therapies, such as Paxlovid from Pfizer Inc. (NYSE: PFE), sotrovimab from GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR), Veklury (remdesivir) from Gilead Sciences, Inc. (NASDAQ: GILD), and molnupiravir from Merck & Co., Inc. (NYSE: MRK), are expected to work against the Omicron variant and are authorized or approved by FDA to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Foghorn Therapeutics (FHTX) Phase 1 Study of FHD-286 Placed on Partial Clinical Hold
- OraSure Technologies (OSUR) on Watch as DOH to Buy Ebola Test
- LumiraDx (LMDX) Reports Five-Minute SARS-CoV-2 Ag Ultra Test Achieves CE Marking
Create E-mail Alert Related CategoriesFDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!