Emergency Use Authorization Granted for GSK-Vir COVID-19 Antibody

FDA recently issued an emergency use authorization (EUA) for GSK and Vir Biotechnology’s COVID-19 antibody therapy, sotrovimab.

The therapy is intended to treat mild-to-moderate coronavirus in adults and pediatric patients 12 years of age and older who are at high risk for progression to severe COVID-19, including hospitalization or death.

The authorization includes individuals 65 years of age and older who have certain medical conditions, FDA stated.

Notably, sotrovimab is not authorized for patients who are hospitalized or require oxygen therapy due to COVID-19, as there has been no real benefit of this treatment in hospitalized patients and monoclonal antibodies may worsen clinical outcomes. 

“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the announcement.

“It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States,” Cavazzoni continued. 

FDA based its authorization on an interim analysis from GSK and Vir Biotechnology’s Phase 1/2/3 randomized, placebo-controlled clinical trial. 

The COMET-ICE trial assessed the safety and efficacy of a single 500-milligram intravenous infusion of the antibody or a placebo in 583 non-hospitalized participants globally. Of the participants, 291 received sotrovimab and 292 received a placebo within five days of symptom onset.

The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization. 

Overall, researchers found an 85 percent reduction in hospitalization or death in patients who received the antibody as monotherapy compared to placebo.

The issuance of an EUA is different than FDA approval, the agency highlighted. When issuing an EUA, FDA evaluates the totality of available evidence and balances any known or potential risks with any known or potential benefits of the product for use during an emergency.

Based on the agency’s review of COMET-ICE, FDA determined that sotrovimab may be effective in treating adults and certain pediatric patients with mild-to-moderate COVID-19. Overall, the known and potential benefits of the drug outweigh the known and potential risks. 

Although FDA is monitoring viral variants and their sensitivity to monoclonal COVID-19 antibodies, laboratory testing showed that sotrovimab retains activity against the current circulating variants first reported in the UK, South Africa, Brazil, California, New York, and India. 

Sotrovimab will continue to be studied in ongoing clinical trials. An analysis of safety and efficacy data at Day 29 for the full population from the COMET-ICE trial is expected in the first half of 2021. 

GSK also plans to submit a Biologics License Application (BLA) to FDA in the second half of this year.

“The fast pace of COVID-19 vaccinations in the U.S. is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complication,” Hal Barron, MD, chief scientific officer and president of research and development at GSK, said in a statement following the authorization. 

“In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need,” Barron continued. 

George Scangos, PhD, chief executive officer of Vir Biotechnology, also stated that sotrovimab is a critical new treatment option for the current pandemic, demonstrating activity against all known variants of concern and potentially for future coronavirus outbreaks as well.