The U.S. Food and Drug Administration (FDA) has said Merck’s experimental Covid-19 pill is effective against the virus, but has raised concerns about its safety during pregnancy, and said it will seek further evaluation from. external experts on the risks of birth defects and other potential problems in pregnant women.
The FDA released its analysis of the pill ahead of a public meeting next week where academics and experts will evaluate its safety and efficacy. The agency is not obliged to follow the advice of the group.
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The effectiveness drops from 50 to 30 percent
Meanwhile, according to updated data from the Move-Out study released by Merck and Ridgeback Biotherapeutics themselves, the molnupiravir antiviral pill allows for a 30% reduction in the relative risk of hospitalization or death from Covid.
An efficacy that is lower than that reported previously in the interim analysis of the same trial, which reported a halving of the risk (48% reduction).
The two companies communicated the update, explaining that the data of all the participants enrolled in the trial (1,433 people) are now available. In this population, the drug reduced the risk of hospitalization or death from 9.7% calculated in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute reduction in the risk of 3.0% and a relative risk reduction of 30%. 9 deaths were reported in the placebo group, one in the molnupiravir group.
Based on the study design, the final efficacy assessment was considered complete at the planned interim review, when the statistical criterion for success was met and study enrollment was stopped on the recommendation of the External Monitoring Committee. data and after having agreed with the US FDA (Food and Drug Administration).
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Data from the interim analysis showed a reduction in the risk of hospitalization or death from 14.1% (53/377) in the placebo group to 7.3% (28/385) in the molnupiravir group, for an absolute risk reduction of 6.8% and a relative risk reduction of 48%.
“The interim analysis and additional analyzes support the efficacy and favorable overall benefit-risk assessment of molnupiravir for the treatment of mild to moderate Covid-19 in adults at high risk of disease progression,” it reads. in a note.
These additional analyzes have been shared with the FDA and will be presented to the US agency’s specialized committee on November 30th. Merck and Ridgeback Biotherapeutics, the note read, “have conducted a rigorous development program for molnupiravir and believe it has the potential to address a significant unmet medical need for an oral drug for adults with Covid at risk of progression to severe disease. and hospitalization We look forward to working with the FDA and other “regulatory agencies that” review our applications.
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The doubts of scientists about the risks
The FDA scientists said their review identified several potential risks, including possible toxicity and birth defects. Regulators also noted that Merck has collected far less overall safety data on its drug than has collected for other Covid-19 therapies.
All Covid-19 drugs currently authorized by the FDA require an injection that limits their use. If licensed, Merck’s drug would be the first that patients could take home to relieve symptoms and speed recovery.
The approval process
The pill has already been cleared for emergency use in the UK. With cases on the rise in most of the United States, regulators should give the green light to Merck’s drug to help ease the pressure on hospitals.
The FDA review is key to determining who will be eligible and how widely the drug can be prescribed. The US authority will ask its independent consultants if the benefits of the drug outweigh the risks and if its use should be limited with regard to pregnant women.
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