(Washington) The anti-COVID-19 tablet developed by Merck is effective in the treatment of the virus, estimated the United States Medicines Agency (FDA) in a preliminary report published on Friday, however, recommending that it be excluded from use in patients. pregnant women.
The publication comes ahead of a meeting of an FDA expert committee scheduled for November 30, where recommendations for emergency authorization of the drug, named molnupiravir, will be assessed.
If approved, this drug would represent a major breakthrough in the fight against the pandemic by allowing severe forms of the disease to be reduced quite easily.
In its report, the FDA finds molnupiravir effective in patients with COVID-19 at risk of hospitalization.
However, she suggested that the committee not recommend the authorization of molnupiravir in pregnant women, considering that “there is no clinical scenario where the benefits outweigh the risks” in this population.
While no pregnant women were included in the Merck clinical trial, the FDA bases its recommendation on the results of the study in pregnant rats and rabbits, some litters of which had more malformation than in the breast. control groups.
For its authorization request, Merck relied on this clinical trial that 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.
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 the disease.