FDA Approves Merck’s Molnupiravir COVID-19 Pill for Emergency Use

The FDA issued an emergency user authorization for Molnupiravir for the treatment of mild-to-moderate #COVID19 in adults with positive results of direct SARS-CoV-2 viral testing. A study in October showed the drug cut the number of cases leading to hospitalization or death by half in a test group consisting of 775 adults. File photo: G.Tbov, Shutter Stock, licensed.

WASHINGTON, D.C. – Molnupiravir, an anti-viral pill for treating those afflicted with COVID-19 that was developed by pharmaceutical company Merck & Co, was approved for emergency use by the Food and Drug Administration (FDA) on Thursday.

The pill has been approved for use by adults aged 18 and older who have been infected with COVID-19 and are facing potential hospitalization or death due to the virus.

The Kenilworth, New Jersey-based Merck made waves in October when they released the results of a study that showed that molnupiravir cut the number of cases leading to hospitalization or death by half in a test group consisting of 775 adults.

At the time, Dr. Dean Li – Merck’s Vice President of Research – noted that molnupiravir’s performance was greater than expected, and that they would be submitting the drug to the FDA for evaluation.

“It exceeded what I thought the drug might be able to do in this clinical trial,” he said. “When you see a 50 percent reduction in hospitalization or death that’s a substantial clinical impact.”

Molnupiravir wasn’t the only COVID-19 treatment pill that the FDA approved this week; on Wednesday, the organization authorized paxlovin, a similar drug developed by Pfizer. Prior to this week, all COVID treatments consisted of injections or via an IV, but the new approval of pill treatments allow those afflicted with the virus to take an oral medication while remaining at home.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that new treatment options such as molnupiravir and paxlovin are vital as new mutations of COVID – including the high-transmissible omicron variant – continue to emerge.

“It is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” she said.

The FDA noted that molnupiravir and paxlovin are not preventative medicines and cannot take the place of vaccines; in addition, they have not been authorized for use in patients under the age of 18, as they may adversely impact bone and cartilage growth in adolescents.

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