FDA advisers endorse Merck COVID-19 pill
An advisory group for the Food and Drug Administration (FDA) narrowly voted to recommend Merck’s COVID-19 antiviral pill for infected adults at high risk for severe coronavirus illness, hospitalization or death.
The panel endorsed Merck’s five-day oral treatment in a 13-10 vote on Tuesday.
The advisers recommended the FDA authorize the pill, developed with Ridgeback Biotherapeutics, for adult patients enduring mild-to-moderate COVID-19 who face a higher risk of serious illness, including due to underlying health conditions.
Split vote: The close vote came as experts considered concerns about updated data showing the pill linked to a 30 percent reduction in hospitalizations, a decrease in effectiveness from previous research.
Advisers also discussed the potential risks the drug could present for pregnant people and worries that the treatment could spark the virus to mutate into a more dangerous strain.
But several who backed the pill for high-risk infected adults pointed to the ongoing state of emergency amid COVID-19 and the limited treatments for the virus.
Significance: Antiviral COVID-19 drugs have been considered a potential game changer in the pandemic, since all current drugs require an injection or IV.
Approval of these pills could expand accessibility with at-home COVID-19 treatments, pending FDA authorization and Centers for Disease Control and Prevention (CDC) approval.