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Pharmaceutical company Merck said on friday He said the antiviral pill reduced the risk of hospitalization and death among high-risk Covid patients by 30 percent, down from an earlier estimate of 50 percent, in a recent analysis of a clinical trial.
The low efficacy is a disappointment for the drug known as molnupiravir, which health authorities worldwide rely on as a critical tool to save lives and reduce the burden on hospitals. This raises the importance of a similar, ostensibly more effective proposal from Pfizer, which is again under review by the Food and Drug Administration.
A panel of FDA advisors will meet on tuesday To discuss Merck’s treatment and vote on whether it should be recommended to be authorized to treat high-risk Covid patients.
Inside briefing documents Agency reviewers published on the FDA’s website on Friday did not take a position on whether the drug should be authorized, although clinical trial data did not show any major safety concerns and found the drug was effective at preventing serious illness.
Reviewers said they only became aware of the updated event estimate earlier this week and are continuing to review the data. they said can update their reviews when the panel meets on Tuesday.
Merck’s initial estimate that the drug reduced hospitalizations and deaths by 50 percent came with an early look at the results of 775 study participants. The updated figure, released on Friday, came in at more than 1,400. In the final analysis, participants taking molnupiravir had a 6.8 percent risk of being hospitalized and one patient died. Those who took the placebo had a 9.7 percent risk of being hospitalized, and nine died.
An infectious disease researcher at the University of Minnesota, Dr. David Boulware said he hopes the drug will still receive emergency clearance. If the expert committee approves it and the FDA follows the recommendation, the treatment could be allowed in the United States as soon as next week.
“The reduction in hospitalization is slightly less, but there’s still a huge mortality advantage if you start early,” he said.
Still, he said, molnupiravir would likely be considered a lower-level treatment, an alternative choice for people who can’t or don’t want more effective treatments.
In the United States, monoclonal antibody drugs, typically administered intravenously, have been found to reduce hospitalizations and deaths by at least 70 percent. Pfizer’s antiviral pill Paxlovid, which is in a clinical trial where it reduced the risk of hospitalization and death by 89 percent, could be available within weeks. Fluvoxamine, a common and inexpensive antidepressant, seems to be nearly as effective as molnupiravir.
Intended to be distributed in pharmacies and taken at home, Merck’s drug is the first of a new class of antiviral treatments for Covid that is expected to reach many more people than other treatments. Public health experts say the pill is not a substitute for a vaccine, but has the potential to prevent serious illness and save lives.
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