Merck's novel antiviral pill to cure Covid-19 was suggested for emergency use approval by a Food and Drug Administration (FDA) advisory panel, clearing the path for the government to approve the very first oral medicines for treating Covid.
The drug, known as molnupiravir, was voted by the agency's Antimicrobial Drugs Advisory Committee (AMDAC) for treating people with chronic to moderate Covid-19 who are at risk of serious disease or hospitalization.
Prior to voting in favor of the medicine, members of the committee posed various questions as well as voiced concerns about its efficacy and safety during the daylong community meeting.
Following the vote, Dr. Lindsey Baden, AMDAC’s chair, stated that majority of the committee members seemed to fall in the middle when assessing the risks and advantages of the medicine.
According to Dr. Baden, the ones who voted in favor believed that the drug's effectiveness was obvious, albeit with difficulties that must be considered. He highlighted those who were opposing the recommendation as being unconvinced by the findings and citing potential hazards such as injury to the fetus and damage to DNA.
Despite decreased efficacy, Merck’s Covid pills have some benefits. All other FDA-approved treatments necessitate the use of an injection or IV.
Merck scientists anticipate the medicine to act against the novel omicron variant, which was initially detected in South Africa. The variant contains comparable alterations to other variants of the virus. Although, more testing is considerably required.
According to Dr. Sean Curtis, Merck's global regulatory affairs and clinical safety senior vice president, stated that Merck's medicine comes in four 200-milligram capsules that are taken twice a day for five days. He further added that patients must start treatment as soon as symptoms appear.
In Merck's clinical trial, volunteers were given the medicine between five days of the appearance of symptoms.