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GlaxoSmithKline, Vir Apply for FDA Emergency Use of COVID Drug

GSK and VIR have a treatment candidate that showed an 85% reduction in hospitalization or death for patients with COVID-19.
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GlaxoSmithKline plc  (GSK)  and Vir Biotechnology  (VIR)  announced Friday they had submitted an emergency use application to the U.S. Food and Drug Administration for their investigational, dual-action COVID antibody treatment candidate. 

The treatment candidate is for adults and adolescents aged 12 years and older with mild-to-moderate COVID-19 symptoms who are at risk for progression to hospitalization or death. 

Trial data from the companies' study of 583 patients showed an 85% reduction in hospitalization or death for those receiving the drug candidate, VIR-7831, compared to a placebo. 

As result of the study, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to "evidence of profound efficacy." 

The data suggests that VIR-7831 targets a highly conserved portion of the coronavirus spike protein, which may make it more difficult for resistance to the drug to develop. The treatment maintains activity against current circulating coronavirus variants of concern, including the U.K., South African and Brazilian variants

Shares of GlaxoSmithKline were flat at $36.08 on Friday morning, while those of Vir were up 0.13% to $52.77.

The FDA's emergency use authorization allows drugs that have not been approved by the agency to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases when there are no adequate, approved or available alternatives. 

Read More: AstraZeneca Vaccine Release Queried By Anthony Fauci, Health Officials

The FDA previously provided emergency authorization use for the COVID vaccines from Pfizer  (PFE) , Moderna  (MRNA)  and Janssen.

President Joe Biden said Thursday that he was doubling his vaccination goal, aiming to get 200 million COVID-19 shots in the arms of Americans within his first 100 days in office.

"I know it's ambitious, twice our original goal, but no other country in the world has even come close, not even close, to what we are doing," Biden said at his first news conference since becoming president in January.