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November 29, 2021 – Merck’s antiviral pill for COVID-19, molnupiravir, appears to be far less effective than the first results of a clinical trial initially suggest.
According to an analysis by FDA researchers, the experimental pill reduced the risk of hospitalization or death from COVID-19 by about 30% compared with placebo, and the pill showed no benefit for people with antibodies to COVID-19 from previous infections.
The updated analysis showed 48 hospitalizations or deaths among study participants who were randomly assigned to take the antiviral drug, compared with 68 among those who took placebo.
These results come from the full set of 1,433 patients who were randomized to the clinical trial, which became available last week.
The initial results of the first 775 patients included in the clinical trial, which were published in a company announcement in October, say the drug reduces the risk of hospitalization or death for patients at high risk of serious illness by about 50%.
Merck produces millions of doses of molnupiravir, the first antiviral pill to treat COVID-19 infections. The UK’s drug regulator authorized the use of the drug in early November. The company said it expects to distribute the drug worldwide by the end of 2021.
Last month, two Indian pharmaceutical companies stopped late-stage clinical trials of a generic version of molnupivir after studies failed to find a benefit for patients with moderate COVID-19. Studies in patients with milder symptoms are still ongoing.
On Saturday, INNew England Journal of Medicine postponed its planned early publication of the results of the molnupiravir study, citing “new information”.
The drug is intended to be given as four tablets taken every 12 hours for 5 days. It is most effective when taken in the first few days after the onset of new symptoms, something that requires convenient and affordable testing.
The new results appear to place molnupiravir far below the effectiveness of existing treatments.
The REGEN-COV monoclonal antibody infusion cocktail, which the FDA has already approved for emergency use, is about 85% effective in preventing hospitalization or death in patients at risk of severe COVID-19 results, and appears to be just as effective. effective in people who already have antibodies to COVID-19, which is why it is given to both vaccinated and unvaccinated patients, the FDA said.
In early November, Pfizer said its experimental antiviral pill, Paxlovid, reduced the risk of hospitalization or death by 89 percent.
In a briefing released before the advisory committee meeting on Tuesday, the FDA highlighted other potential safety issues with the drug Merck, which acts by causing the virus to make mistakes while copying, which ultimately causes the virus to mutate to death.
The agency asked the advisory committee to assess the correct patient population for the drug: Should pregnant women receive it? Can the drug harm a developing fetus?
Should vaccinated people with breakthrough infections get it? Will they work? People with reduced immune function are more likely to get a breakthrough infection. They are also more likely to shed the virus over a longer period of time, making them perfect incubators for variants. What could happen if we give this type of patient a drug that increases mutations?
And what about mutations caused by the drug? Can they increase the potential for more options? The agency concluded that the risk of this happening is small.
In animal studies, the drug affects bone formation. For this reason, the agency has agreed with the pharmaceutical company that molnupiravir should not be given to people under 18 years of age.
In addition to these concerns, the FDA says there are no serious safety issues among the people who participated in the clinical trial, although they acknowledge that the number is small.
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