Pfizer is similarly seeking approval for its own oral Covid treatment pill that it said was 89% effective in preventing hospitalization and death when administered with a popular HIV drug.
Merck, in its initial application and presentation to the FDA advisory committee on Tuesday, said the pill was 50% effective at reducing the risk of hospitalization or death in an interim analysis of 762 patients.In a post-interim analysis of 646 participants, hospitalization and deaths were actually higher in the group that took the pill, at 6.2%, compared with those in the placebo group who didn't take the drug, at 4.2%."However, there were also more women in the second part of the study, and that's been associated with what we can see with less risk, as well as more patients who were antibody positive," he said.Kartsonis told the FDA advisory committee that based on the interim analysis of 762 participants, molnupiravir significantly reduced the risk of hospitalization or death during the clinical trial, with nine out of 10 deaths occurring in the placebo group, which didn't receive the medication.Merck did not identify any safety concerns associated with molnupiravir during the clinical trial, according to Kartsonis.FDA scientists, in a briefing prepared for the committee, said animal studies found that the drug can result in reduced fetal body weight and abnormal bone formation?Janet Cragin, a medical officer at the CDC's birth defects division, said it wouldn't be ethical to prescribe molnupiravir during pregnancy given the potential side effects, but denying the drug to a pregnant woman suffering from Covid is also problematic.
"Pregnancy itself can be considered a risk factor for progression to severe Covid illness," she said.Robert Heflich, director of the FDA's genetic and molecular toxicology division, said the risk of molnupiravir altering human genes in a clinical setting is low, given that the drug clearly was not mutagenic during a study in rodents