November 29, 2021 – Merck’s antiviral pill for COVID-19, molnupiravir, appears to be much less effective than initial clinical trial results first suggested.
According to an analysis by FDA scientists, the experimental pill reduced the risk of hospitalization or death from COVID-19 by about 30%, compared to a placebo, and the pill showed no benefit for people with prior COVID-19 antibodies. infection.
The updated analysis showed 48 hospitalizations or deaths among study participants who were randomized to take the antiviral drug, compared to 68 among those who took a placebo.
These results come from the full set of 1,433 patients randomized to the clinical trial, which just became available last week.
The first results of the first 775 patients included in the clinical trial, which were published in a press release from the company in October, indicated that the drug reduced the risk of hospitalization or death for them by about 50%. patients at high risk of serious illness.
Merck has produced millions of doses of molnupiravir, which is the first antiviral pill to treat COVID-19 infections. The UK’s medicines regulator cleared the drug for use in early November. The company said it plans to distribute the drug globally by the end of 2021.
Last month, two Indian pharmaceutical companies halted late-stage clinical trials of a generic version of molnupiravir after studies found no benefit for patients with moderate COVID-19. Trials in patients with milder symptoms are still ongoing.
Saturday, TheNew England Journal of Medicine postponed the anticipated early publication of the results of the molnupiravir study, citing “new information”.
The drug is designed to be administered as four tablets every 12 hours for 5 days. It is most effective when taken in the first few days of new symptoms appearing, which requires convenient and affordable testing.
The new results appear to place molnupiravir well below the effectiveness of existing treatments.
REGEN-COV infused monoclonal antibody cocktail, which the FDA has already cleared for emergency use, is approximately 85% effective in preventing hospitalization or death in patients at risk of severe consequences from COVID-19 , and it seems to be just as 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%.
In backgrounders released ahead of an advisory committee meeting on Tuesday, the FDA highlights other potential safety concerns with the drug Merck, which works by causing the virus to make mistakes when it copies itself, ultimately causing the mutation of the virus until death.
The agency asked the advisory committee to comment on the right patient population for the drug: Should pregnant women get it? Could the drug harm a developing fetus?
Should vaccinated people with chronic infections get it? Would it work for them? People with reduced immune function are more likely to get a breakthrough infection. They are also more likely to shed the virus for a longer period of time, making them perfect incubators for variants. What could happen if we gave this type of patient a drug that increases the mutations?
And what about mutations caused by the drug? Could they increase the potential for more variations? The agency concluded that the risk of this happening was low.
In animal studies, the drug had an impact on bone formation. For this reason, the agency has agreed with the drug company that molnupiravir should not be given to anyone under the age of 18.
Aside from these concerns, the FDA says there were no major safety concerns among people who took part in the clinical trial, although they acknowledge that the number is low.