On Tuesday, Nov. 30, the Food and Drug Administration (FDA) announced that a panel closely endorses Merck’s first tightly monitored COVID-19 pill.
The FDA voted 13-10 that the advantages of an antiviral medicine called “molnupiravir” exceed the hazards of using it during pregnancy, such as the possibility of birth abnormalities.
This announcement facilitates the approval of the first medicine to treat the coronavirus that Americans may use at home.
According to the vote, the medicine is provided for people with mild to moderate COVID-19 sickness and those who are at the greatest risk. This includes the elderly, as well as persons who suffer from obesity or asthma.
According to most experts, the medicine should also not be used by vaccinated persons who were not a part of the Merck research and have not been demonstrated to benefit.
Most proponents of the medicine caution that “molnupiravir” should not be given to anyone pregnant. They added that the FDA should issue further warnings before prescribing it.
The FDA is said to make its conclusion before the end of the year, reports AP.
Merck stated that it has not explicitly tested its medicine against the new variant (omicron), but it is likely successful against other coronavirus types.
On Friday, Nov. 26, Merck reported that final research data showed that “molnupiravir” lowered hospitalization and death risks in adults with coronavirus by 30% compared to individuals receiving a placebo. It first claimed a 50% decrease based on preliminary results.
The new medicine works by inserting microscopic faults into the coronavirus’s genetic code, preventing replicating. The drug’s genetic effect has sparked fears that it could foster the spread of more aggressive virus forms.
On Tuesday, Nov. 30, FDA officials acknowledged the risk was speculative, but many panelists suggested it should be closely examined in future research.
Meanwhile, Pfizer, a rival pharmaceutical company, is close behind with its medication under assessment.
Pfizer’s drug belongs to the family of protease inhibitors, is part of a long series of antiviral medications, and doesn’t raise the same type of concerns regarding mutations that Merk’s drug possesses.
Pfizer claimed last week that omicron mutations would not affect their drug.