One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks.
Whether it’s the highly mutated Omicron variant emerging in South Africa as biopharma researchers scramble to create custom-made vaccines in record time or the institutional mandates juxtaposed with waning vaccine immunity and the ongoing ups and downs of cases and deaths, the SARS-CoV-2 virus continues to dig its ugly spikes into an uncertain and anxious world.
Stimulating the innate immune system with defective viral genomes (DVG)-based strategy provided broad-spectrum protection against RNA viral infections, including SARS-CoV-2 and other respiratory diseases in animal models, according to a U.S.-led international collaborative study reported in the Nov. 17, 2021, edition of Cell.
While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season, and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies.
Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19 and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19.
A divided FDA advisory committee voted 13-10 Nov. 30 that the known and potential benefits of the Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, outweighs its known and potential risks. If granted an emergency use authorization (EUA), molnupiravir would become the first take-at-home oral drug in the U.S. to keep mild and moderate COVID-19 infections from becoming severe in high-risk adults.