This request concerns the drug called molnupiravir, intended for the treatment of adult patients with mild to moderate forms of Covid-19.
The American laboratory Merck announced Monday that it had requested emergency authorization in the United States for its pill against Covid-19, an easy-to-administer remedy called to become a crucial tool in the fight against the pandemic, because it is complementary to vaccines.
Given to patients within days of a positive test, the treatment halves the risk of hospitalization and death, according to a clinical trial conducted by Merck, also called MSD outside the United States. If approved, this drug called molnupiravir would represent a major breakthrough in reducing severe forms of the disease quite easily.
“The extreme consequences of this pandemic demand that we act with unprecedented urgency, and that is what our teams have done by submitting this request (for authorization) for molnupiravir.“To the United States Medicines Agency, the FDA,”within ten days after receiving the dataOf the clinical trial, said Robert Davis, boss of the company, quoted in a press release.
Merck clarified that “actively with regulatory agencies around the world to submit emergency use or marketing authorization requests in the coming months“. This type of treatment with tablets, which can be simply taken at home with a glass of water, is eagerly awaited.
In anticipation, the group has already started large-scale production of molnupiravir and plans to manufacture the doses needed for 10 million treatments by the end of the year. And Merck has already made deals with some states, including the United States, that have plans to buy 1.7 million if molnupiravir is approved.
Antivirals like molnupiravir work by decreasing the ability of a virus to replicate, thereby slowing down the disease. Their application can be twofold: both to allow people already affected not to suffer from serious symptoms, but also to those who have been in close contact not to develop it. Merck is therefore also in the process of conducting a separate clinical trial for this second use, as a preventive measure.
For its request Monday, the American company is based on the clinical trial it conducted with its partner Ridgeback Biotherapeutics on people with mild to moderate cases of Covid-19, 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. As the market is potentially huge, several laboratories have positioned themselves in this niche.
Pfizer is currently testing its own antiviral treatment, called PF-07321332, on thousands of people, both to assess its effectiveness on people already infected with Covid-19, as well as in those close to a person who has contracted the virus. disease, in order to prevent them from developing it in turn.