Emory University Invented COVID-19 Pills Awaiting FDA Approval To Treat Symptoms

ATLANTA — A COVID-19 pill designed at Emory University is one of two being reviewed by the U.S. Food and Drug Administration for clearance to be available at local pharmacies.

Merck and Pfizer developed the pills to treat mild COVID-19 cases and are awaiting FDA approval that could come by the end of the year. At least initially, the federal government will put caps on the number of pills physicians can order for their patients.

Pfizer announced Tuesday that the trial of its Paxlovid oral medication “reduced the risk of hospitalization or death for any cause by 89%” within three days of symptoms showing.

The Merck product, Molnupiravir, was developed by the Drug Innovation Ventures at Emory and was authorized earlier this year by the British Medicines and Healthcare products Regulatory Agency, Emory officials said. The FDA’s Antimicrobial Drug Advisory Committee late last month voted that the known and potential benefits of the drug outweighed the known and potential risks, Merck reported.

There will be other challenges to maximizing the effectiveness of the drugs. Patients will have to take 30 to 40 pills in a five-day period, and they will need to begin treatment within three days after they are infected.

Health experts worry high-risk patients infected with COVID-19 may not be able to get tested and treated in that three-day timeframe. Studies of a similar drug used to limit the impact of influenza show that only 40 percent of high-risk patients got diagnosed within the three-day window to begin treatment.

Neither offering replaces vaccinations, but provides treatment options that reduce the effects of mild cases, developers say. As the nation approaches the grim milestone of 800,000 deaths to COVID-19 and a new variant of the virus has emerged, Pfizer and Merck officials showed some excitement about the place they find their medication in the regulation process.

“This news provides further corroboration that our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of PAXLOVID in reducing hospitalization and death and show a substantial decrease in viral load. This underscores the treatment candidate’s potential to save the lives of patients around the world,” Pfizer Chairman and Chief Executive Officer Albert Bourla said. “Emerging variants of concern, like omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”

Pfizer last week announced that its vaccine has proven effective against the omicron variant.

Merck officials also lauded the regulation progress of its pill.

“The positive outcome of today’s FDA Advisory Committee meeting, following a comprehensive review of Molnupiravir, including the compelling data from the MOVe-OUT study demonstrating a significant reduction in hospitalizations and deaths, is a critical step toward bringing this promising oral medicine for COVID-19 to appropriate patients in the U.S.,” Merck Research Laboratories Executive vice president and president Dean Y. Li said last month in a statement.

See Also:

• 3rd GA Omicron Variant Case Confirmed In Metro Atlanta
• Vaccine Booster Can Prevent Omicron Coronavirus Variant: Pfizer