December 23, 2021 – The FDA approved the emergency use of Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.
Similar to FDA approval for another antiviral pill regimen – ritonavir plus nirmatrelvir or Paxlovid – approved by Pfizer on Wednesday, molnupiravir (brand Lagevrio) should be taken early during COVID-19 disease.
Pfizer’s medicine is allowed for all people over 12 years of age. But Merck’s is only for adults ages 18 and up.
Merck applied to the FDA in October for approval for emergency use. The company included the results of its phase III study showing that treatment could lead to a 50% reduction in COVID-19 hospitalizations. Later data showed that this efficiency was closer to a 30% reduction. In November, the FDA’s advisory council narrowly recommended the agency’s approval with 13-10 votes.
Animal studies have shown that the drug can harm the fetus, so it is not recommended for pregnant women, says the FDA. It can be prescribed to pregnant women only after their doctor has determined that the benefits outweigh the risks and that the patient is informed of these risks.
Women who could become pregnant should use a reliable method of birth control if they are being treated with molnupiravir for 4 days after the final dose.
Two weapons against COVID
Two antiviral pills could be better than one, at least in terms of the availability of more anti-COVID-19 drugs in early 2022. It remains to be seen whether drug manufacturers will be able to track demand, which could increase significantly with the expected increase in Omicron variants.
Ritonavir and molnupiravir join remdesivir (Veklury brand) as available antiviral drugs for the treatment of COVID-19. Remdesivir is fully FDA approved, but is only given through IV people in the hospital.
Officials point out that treatments for COVID-19 in tablet form are more appropriate for patients in the U.S. and around the world, especially where IV infusion services may be limited.
In March 2021. experts exactly predicted that the molnupiravir pill will be available by the end of the year.
Interestingly, in September Merck published the results of laboratory studies that suggest that molnupiravir work against variants SARS-CoV-2 because the agent does not target the spiky protein of the virus.
Perhaps in part because of the promising early results, the U.S. government announced plans in November to buy molnupyvir worth $ 1 billion. That new order came on top of $ 1.2 billion tablets the U.S. ordered in June.