Merck’s Covid-19 Antiviral Pill: In a split decision, an FDA panel supports Merck’s COVID medication

A panel of specialists advising the Food and Drug Administration narrowly decided in favour of authorising an antiviral tablet from Merck and Ridgeback Biotherapeutics for emergency use in the treatment of COVID-19.

Authorization was approved by a vote of 13 to 10. The FDA is not required to adopt its experts’ recommendations, although it frequently does.

If the FDA approves the medicine, molnupiravir, it will be the first oral antiviral treatment for COVID-19 that can be used at home. The FDA is also considering authorising Pfizer’s second oral medication, Paxlovid.

Merck’s Covid-19 Antiviral Pill

The Merck medicine is given twice daily for five days and works by inducing a cascade of SARS-CoV-2 coronavirus-disabling mutations during replication. The medication is indicated for patients with mild to moderate sickness who are at high risk of acquiring severe COVID-19 infection. It is recommended that you take it within five days after developing symptoms.

Molnupiravir, according to an interim review of a clinical study, reduced the risk of hospitalisation or death in half. 7.1 percent of those who received the medicine ended up in the hospital or died, compared to 14.1 percent of those who received the placebo. However, the final analysis of the trial, announced Friday, revealed a 30% reduction in the risk of hospitalisation or death.

According to an FDA summary, participants in the medication group were more likely to be hospitalised or die in the second half of the study than those in the placebo group. The drug’s protective effect against death observed in the first half of the study was lost in the second.

When committee head Dr. Lindsey Baden questioned Dr. Nicholas Kartsonis, a Merck senior vice president, he responded, “I don’t have a satisfactory answer to your question.”

The medication’s capacity to trigger changes outside the virus, as demonstrated in several laboratory and animal testing, prompted several safety concerns that were discussed extensively throughout the daylong discussion. The council considered the likelihood of birth malformations and expressed reservations about providing the medicine to pregnant women. However, the medicine may have some benefits for them as well.