Merck Approaches FDA for Approval of its Covid-19 Pill for At-Home Use
U.S. drug company Merck and its Canada-headquartered partner Ridgeback Biotherapeutics on Monday filed an application asking the U.S. Food and Drug Administration to approve their Covid-19 pill, a move that pushes the U.S. closer to what many believe will be a turning point in the battle against the pandemic: an effective drug for use at home.
2021-10-12 13:36:46 - VI News Staff
The filing comes approximately two weeks after the companies announced that their experimental Covid-19 pill significantly helped high-risk people in the early stage of infection from becoming seriously ill or dying.
The FDA could approve the drug in the coming weeks, ahead of what some health experts predict could be another deadly winter, especially among the unvaccinated.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Merck Chief Executive Robert Davis.
The pill, named molnupiravir, reduced the risk of hospitalization or death by approximately 50 percent. Merck said it has been so effective that the companies — at the recommendation of an independent data monitoring committee and in consultation with the U.S. Food and Drug Administration — stopped enrollment in its late-stage trial early due to the positive results.
The experiment evaluated data from 775 patients who were initially enrolled in the phase 3 of the trial on or prior to Aug. 5, 2021. At the time of the decision to stop recruitment based on the compelling interim efficacy results, the trial was approaching full recruitment of the phase 3 sample size of 1,550 patients, with more than 90 percent of the intended sample size already enrolled, Merck said.