The US Food and Drug Administration (FDA) plans to grant Emergency Use Authorization for two types of pills to treat COVID-19, manufactured respectively by Pfizer, and by Merck.
The authorization could come as soon as Wednesday, according to a report published by Bloomberg News, quoting sources familiar with the situation.
Both medications are seen as promising new oral treatments of the deadly disease.
They are supposed to be ingested at home upon onset of symptoms and are believed to help prevent hospitalization and death from COVID-19.
Paxlovid, manufactured by Pfizer, showed nearly 90 percent efficacy in preventing hospitalization and death in high-risk adults. The medication combins two active substances, PF-07321332 and ritonavir, which are available as separate tablets and should be taken together twice a day for five days.
Molnupiravir, manufactured by Merck together with Ridgeback Biotherapeutics, was somewhat less effective.
The Merck medication showed 50 percent efficacy in reducing hospitalization and death in a clinical trial of high-risk patients who took the medication early in the course of their illness. Risk factors in the Phase II-III trial included age (> 60 years), active cancer, chronic kidney disease, COPD, obesity, diabetes or serious heart conditions such as heart failure and coronary artery disease.
The US has already purchased 10 million courses of Paxlovid, and five million courses of Molnupiravir.
Britain has already approved Molnupiravir for use by people with mild to moderate COVID-19 and who have at least one risk factor for developing severe illness, according to Reuters.
The human medicines committee of the European Medicines Agency (EMA) has not yet authorized Paxlovid for use in the European Union, but issued “advice” that can “now be used to support national recommendations on the possible use of the medicine before marketing authorization,” the EU said in a statement.
