Patients will want a prescription and will begin taking the tablet inside 5 days of experiencing signs. The remedy is taken twice a day for 5 days.
Clinical trials confirmed that Merck’s tablet diminished the danger of hospitalization and demise from the virus by 30 p.c.
“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, while continuing to generate additional data on their safety and effectiveness,” stated Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research.
The FDA on Wednesday approved the nation’s first antiviral tablet for Covid — Pfizer’s Paxlovid — which the company stated must be an necessary device for serving to scale back the present pressure on hospitals flooded with Covid sufferers and grappling with well being employee shortages. In medical trials, Pfizer’s remedy diminished the danger of hospitalization and demise by 89 p.c when taken three days after the onset of signs.
The authorizations come as Omicron has been detected in all 50 states, resulting in a surge in new infections. More than 60,000 Americans are at the moment hospitalized with Covid-19, in accordance with the Centers for Disease Control and Prevention, and the nation is recording greater than 160,000 new infections on daily basis.
These drugs, which might be taken at residence, are anticipated to succeed in much more folks than monoclonal antibody medicine, that are usually infused in a medical setting, and had, till this week, been the one approved remedy for Covid-19 sufferers who usually are not hospitalized.
The Biden administration has already bought 3.1 million programs of molnupiravir and 10 million programs of Paxlovid.
Katherine Ellen Foley contributed to this report.