FDA OKs Emergency Use of Merck Pill for COVID-19

dWeb.News Article from Daniel Webster dWeb.News

Dec. 23, 2021 — The FDA has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen — ritonavir plus nirmatrelvir, or Paxlovid — granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone age 12 and up. But Merck’s is only for adults ages 18 and older.

Merck applied for an FDA emergency use authorization in October. The company included results of its phase III study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Fetus studies have shown that the drug can cause harm to the fetus. The FDA states that it is not recommended for pregnant women. If the doctor has determined that the risks outweigh the benefits, the drug may be prescribed to pregnant women. Women who are likely to become pregnant with molnupiravir should use reliable birth control for at least 4 days after their last dose.

Two Weapons Against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It remains to be seen whether the drugmakers can keep up with the demand. This could be significantly increased by an increase in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. The FDA has approved Remdesivir, but it is only given to patients in a hospital via an IV.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the U.S. and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part due to promising early results, the U.S. government declared in November its intention to buy $1 billion worth molnupiravir. This new order was in addition to $1.2 billion worth pills that the U.S. had ordered in June.

Read More

For mor dWeb.News Health and Medical News at https://dweb.news/news-sections/health-medical-news/

The post FDA OKs Emergency Use of Merck Pill for COVID-19 appeared first on dWeb.News dWeb.News from Daniel Webster Publisher dWeb.News – dWeb Local Tech News and Business News

dWeb.NewsRead More

Similar Posts