The U.S. Food and Drug Administration authorized the Merck anti-covid coronavirus pill on Thursday, just one day after it OK’d the use of Pfizer’s pill for the treatment of the virus.
Called molnupiravir, the pill had already been authorized for use in the United Kingdom several weeks ago in the fight against Covid-19.
Developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, molnupirtavir will be the second arrow in the quiver that physicians can use to treat the virus at home; to be taken days after people experience symptoms, it is hoped that the pill will keep those suffering fro the coronavirus out of health facilities at a time when the Delta variant is making hospitalizations surge.
The pill is to be given only to high-risk patients by a prescription that can be obtained by one’s health care provider.
Merck anti-Covid pill authorization puts second such treatment on US market
Similarly, Pfizer’s pill, called Paxlovid, will also be prescribed for high-risk patients over the age of 12 who have already exhibited signs of the coronavirus.
Molnupiravir was shown to reduce hospitalizations and deaths by approximately 30% in a clinical trial of high-risk individuals who had taken the drug soon after they had contracted the illness.
The Pfizer pill proved to be approximately 90% effective in preventing hospitalizations and deaths in patients who were already at high risk of severe illness, according to the results of its trial.
The markedly lower efficacy of the Merck pill compared with the Pfizer product may impact how widely it is accepted by physicians and the public.
The FDA authorized the pill for use in the treatment of what they called mild-to-moderate COVID-19 in adults who find themselves at risk for severe disease. They must also be deemed as those for whom other coronavirus treatments are either not accessible or clinically appropriate.
Thursday’s decision follows a vote in favor of authorization that passed narrowly by a panel of advisers to the FDA on November 30.
Considering how the fourth wave of the virus continues to clog hospital ICUs, making many institutions delay other types of treatments and straining health care workers to their limits, the pills come as very welcome news.
Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, stated today “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization.”
Molnupiravir will not be given to patients younger than 18 due to the concern that it may affect the growth of bone and cartilage, the FDA noted.
The Merck product is also more expensive than the Pfizer pill, at $700 per course. The U.S. government has contracted for 10 million courses of the Pfizer pill at a price of $530 per course; it has a deal with Merck for up to 5 million courses of molnupiravir.