BLOOMBERG LAW - The future of Covid-19 treatment is cloudier after the FDA approved Gilead Sciences Inc.'s remdesivir, the first virus treatment to get full authorization in the U.S. The approval marks a major turning point for the U.S. in the fight against Covid-19 and solidifies the standard of care for hospitalized virus patients in the U.S. Shortages of remdesivir—which have been an issue throughout the pandemic—are especially problematic now that it’s been approved because supply issues could slow down the development of other new Covid-19 drugs that might now be required to use it in their clinical trials. Some providers also question whether the approval was premature given the state of research on the drug.
The approval doesn’t necessarily block other virus treatments from being authorized, “but it probably makes it a bit more difficult or at least uncertain” how other products will fare moving forward, said HPM's Walid Gellad, director for Pitt's Center for Pharmaceutical Policy and Prescribing. That’s because drugs can only receive an emergency use authorization if there are no “adequate, approved, and available alternatives,” and how future products will hold up in that analysis is unclear now that there’s an approved treatment.
Read full story