The American laboratory Merck announced on Monday that it had filed an emergency authorization request with the American Medicines Agency, the FDA, for its pill which, according to a clinical trial, reduces the risk of hospitalization and death by two. of patients with Covid-19.
If approved, this drug called molnupiravir would represent a major advance in the fight against the pandemic by making it possible to reduce the severe forms of the disease quite easily.
Upcoming marketing requests around the world
“The extreme consequences of this pandemic demand that we act with unprecedented urgency, and this is what our teams have done by submitting this request (for authorization) of molnupiravir to the FDA,” said Robert Davis, boss of the company, cited in the press release.
This type of treatment with tablets, easy to administer, is eagerly awaited and seen as an effective way to fight the pandemic.
Merck said it is working “actively with regulatory agencies around the world to submit emergency use or marketing authorization requests in the coming months.”
A clinical trial deemed conclusive
For its authorization request, Merck is relying on the clinical trial it conducted with its partner Ridgeback Biotherapeutics on people with mild to moderate cases of coronavirus and at least one aggravating risk factor. They received the treatment within five days of the first symptoms.
The rate of hospitalization or death in patients who received the drug was 7.3%, compared with 14.1% in those who received placebo. No deaths were observed in people treated with molnupiravir, compared to 8 in the second group.
The results were convincing enough that an independent data monitoring committee, in consultation with the FDA, decided to stop the trial prematurely.