Pfizer CEO Dr. Albert Bourla recently said that patients who relapse after completing a course of the COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) could continue taking the drug. “Paxlovid does what it has to do: it reduces the viral load,” Bourla told Bloomberg. “Then your body is supposed to do the job.” “While the…
Gilead notches remdesivir indication to treat young children
FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19. The indication is limited to children who are either hospitalized or have…
FDA authorizes Pfizer’s Paxlovid oral COVID-19 antiviral
Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) became the first oral SARS-CoV-2 antiviral to win emergency use authorization (EUA). The EUA covers the use of the drug to treat mild-to-moderate COVID-19 in patients who are at least 12 and weighing at least 40 kg (88 pounds). The agency has yet to officially…
FDA advisory panel to weigh in on molnupiravir
An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19. Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations. The benefit-risk calculation for molnupiravir has grown more complicated recently. Over the…