With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution might take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization (EUA) request for what could be the first take-at-home oral drug authorized to treat COVID-19 infections.
Molnupiravir, the take-at-home pill from Merck & Co. Inc. hailed as a potential game-changer against COVID-19, is not as effective as previously thought, according to newly released trial data from the company.
Roche Holding AG is walking away from a deal with Atea Pharmaceuticals Inc. to co-develop the COVID-19 oral antiviral treatment AT-527 after the mid-October failure of a global phase II study testing the medicine in non-hospitalized adults with mild or moderate disease missed its primary endpoint. Roche’s decision tosses the rights and licenses back to Atea so it can continue its development and commercialization efforts.
A futility analysis of Molecular Partners AG’s ensovibep for treating hospitalized COVID-19 adults prompted an independent data safety monitoring board to recommend discontinuing recruitment of patients in the phase III ACTIV-3 study.
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said.
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
Phase II results from Atea Pharmaceuticals Inc. with AT-527 in COVID-19 treatment had pundits scrambling to stack the odds of success for the direct-acting oral antiviral against those of Merck & Co. Inc.’s molnupiravir, though cross-trial comparisons are beset by the usual hurdles, with two especially dramatic ones.
Blocking the interaction between two dengue virus (DENV) nonstructural proteins, NS3 and NS4B, with a newly developed small-molecule inhibitor resulted in potent antiviral activity in mouse models, according to an international collaborative study led by scientists at the University of Leuven (KU Leuven), CD3 the Centre for Drug Design and Discovery in Leuven, and Janssen Pharmaceutica in Beerse, Belgium.
If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.
