The tablet against Covid-19 developed by the laboratory Merck It is effective in treating the virus but not recommended for use in pregnant women, the US Drug Agency (FDA) said in a preliminary report released Friday.
The release comes ahead of an FDA expert committee meeting scheduled for Nov. 30, where recommendations for emergency authorization of the drug, called molnupiravir, will be reviewed.
If approved, this drug would represent a breakthrough in the fight against the pandemic by allowing severe forms of the disease to be reduced quite easily.
In its report, the FDA considers that molnupiravir is effective in patients with Covid-19 and at risk of hospitalization. However, he indicated that the committee does 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.
Yes OK pregnant women were not included in the Merck clinical trial, the FDA bases its recommendation on the results of the study in pregnant rats and rabbits, some of which had more malformations than in the control groups.
For your authorization request, Merck was based on this clinical trial that he conducted with his partner Ridgeback Biotherapeutics in people with mild to moderate cases of Covid-19 and at least one aggravating risk factor. All 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% for those who received placebo. No deaths were seen in people treated with molnupiravir, compared with 8 in the second group.
The results were conclusive enough that an independent data surveillance committee decided, in consultation with the FDA, to abandon the trial prematurely.
Antivirals such as molnupiravir decrease the ability of a virus to replicate, slowing down the disease.
Its application can have a double effect: allowing people already sick with coronavirus not to develop serious symptoms and those who were in close contact with someone infected not to develop the disease.