FDA clears Merck’s antiviral pill against COVID-19

December 23, 2021


Dec 23 (Reuters) – The U.S. Food and Drug Administration (FDA) cleared Merck & Co’s antiviral pill against COVID-19 for high-risk adult patients on Thursday, a day after giving Green light to another similar treatment from Pfizer Inc aimed at high-risk patients over 12 years of age.

Merck’s antiviral pill, molnupiravir, made by Ridgeback Biotherapeutics, was shown to reduce hospitalizations and deaths by about 30% in a clinical trial in high-risk individuals in the early phase of the disease.

The US agency authorized the oral drug for the treatment of mild and moderate COVID-19 in adults who present risks of serious disease and for whom alternative treatments are not accessible or clinically appropriate.

The pill’s approval came after a close vote by an FDA advisory panel on Nov.30.

The drugs from Merck and Pfizer could be promising tools for those infected with COVID-19, especially in the face of the omicron variant, which now predominates in the United States due to its rapid spread.

“As new variants of the virus continue to emerge, it is critical to expand the nation’s arsenal of COVID-19 therapies with emergency use authorizations,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The use of the drug is not authorized for those infected under 18 years of age because it can affect bone and cartilage growth, according to the FDA. Pfizer’s drug was approved Wednesday for people 12 and older.

Pfizer’s antiviral, Paxlovid, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe disease, according to clinical trial data.

The lower effectiveness of Merck’s drug compared to Pfizer’s could hurt future sales.

The US government’s contract to purchase 10 million of Pfizer’s pills at a value of $ 530 each compares with the agreement with Merck to purchase up to 5 million molnupiravir treatments at a price of $ 700 per unit. (Reported by Manas Mishra and Mrinalika Roy in Bengaluru; Edited in Spanish by Valentine Hilaire / Gabriela Donoso)