The anti-COVID tablet developed by Merck is effective in treating the virus, the United States Medicines Agency (FDA) said in a preliminary report released on Friday. However, it recommends excluding its use in pregnant women.
The publication comes ahead of an FDA expert committee meeting scheduled for November 30, where recommendations for emergency authorization of the drug, called “molnupiravir”, will be assessed.
If approved, this drug would represent, according to experts, a major breakthrough in the fight against the pandemic, by making it possible to reduce the severe forms of the disease quite easily.
Merck released the full results of the tablet’s clinical trial on Friday, according to which the drug would reduce hospitalization and death rates by 30% – well below the initial figure – in at-risk patients who took it little after being infected.
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.
Merck first said the pill, in a clinical trial, cut hospitalization and death rates in half, before revising that information downward in Friday’s full results.
The interim results were seen after a study of just over 700 patients, half of whom received the tablet, the other half a placebo.
They were convincing enough that an independent data monitoring committee, in consultation with the FDA, decided to stop the trial prematurely.
The full results come from the analysis of more than 1,400 patients, leading to the more modest reduction in the rate of hospitalization and death.
The interim and comprehensive results both support “the efficacy and overall favorable benefit / risk assessment of molnupiravir” for the treatment of mild to moderate COVID-19 in high-risk adults, Merck said in a statement.
According to the full results, the hospitalization rate in patients who received the drug was 6.8%, compared to 9.7% in those who received a placebo.
One death was observed in people treated with molnupiravir, compared to 9 in the second group.
Antivirals such as 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 severe symptoms and those who have been in close contact not to develop the disease.