Merck says its Covid pill is less effective in final analysis

The pharmaceutical company Merck said friday that in a final analysis from a clinical trial, its antiviral pill reduced the risk of hos...

The pharmaceutical company Merck said friday that in a final analysis from a clinical trial, its antiviral pill reduced the risk of hospitalization and death in high-risk Covid patients by 30%, compared to an earlier estimate of 50%.

The lesser effectiveness is a disappointment for the drug, known as molnupiravir, which health officials around the world rely on as an essential tool to save lives and reduce the burden on hospitals. This increases the importance of a similar, apparently more effective, offering from Pfizer which is also under review by the Food and Drug Administration.

A panel of FDA advisers is meet Tuesday to discuss Merck’s treatment and vote on whether to recommend that it be allowed to treat high-risk Covid patients.

In information documents published on the FDA website on Friday, the agency’s reviewers did not take a position on the drug’s authorization, although they found that clinical trial data showed no major safety concerns and that the drug was effective in preventing serious illness.

Reviewers said they only saw the updated efficacy estimate at the start of this week and are still reviewing the data. They said they could update their rating when the panel meets on Tuesday.

Merck’s initial estimate that the drug reduced hospitalizations and deaths by 50 percent came from an initial examination of the results of 775 study participants. The updated figure announced on Friday came from more than 1,400. Ultimately, participants who received molnupiravir had a 6.8% risk of hospitalization and one patient died. Those who received a placebo had a 9.7 percent risk of being hospitalized and nine died.

Dr David Boulware, an infectious disease researcher at the University of Minnesota, said he expected the drug to still receive emergency clearance. If the expert panel approves it and the FDA heeds the recommendation, the treatment could be approved in the United States as early as next week.

“The reduction in hospitalizations is a bit less, but there is still a big advantage in terms of mortality if you start early,” he said.

Still, he said, molnupiravir will likely be seen as a lower level treatment, an alternative choice for people who can’t get or don’t want more effective treatments.

Monoclonal antibody drugs, which are typically administered intravenously in the United States, have been shown to reduce hospitalizations and deaths by at least 70%. Pfizer’s antiviral pill, Paxlovid, which was found in a clinical trial to reduce the risk of hospitalization and death by 89%, could be available within a few weeks. Fluvoxamine, a common and inexpensive antidepressant, seems to be about as effective like molnupiravir.

Intended to be dispensed in pharmacies and taken at home, Merck’s drug is the first in a new class of antiviral treatments for Covid that are expected to affect many more people than other treatments. Public health experts say that while the pills are not a substitute for vaccination, they have the potential to prevent serious illness and save lives.

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Newsrust - US Top News: Merck says its Covid pill is less effective in final analysis
Merck says its Covid pill is less effective in final analysis
Newsrust - US Top News
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