In news that gives hope to confront CoronaThe US Food and Drug Administration (FDA) announced that the anti-Covid pill developed by Merck is effective in treating the virus, but it recommends that it not be used by pregnant women.
The publication of the report comes ahead of a meeting of the Food and Drug Administration’s expert committee scheduled to be held on November 30, where recommendations will be evaluated with the aim of allowing emergency use of this drug known as “molnopiravir”. If approved, this drug would constitute a major advance in the fight against the epidemic by allowing serious forms of the disease to be easily reduced.
And the Food and Drug Administration said in a preliminary report published Friday, that the drug is effective in patients with…COVID-19 They are at risk of being hospitalized.
There is no clinical scenario
However, she suggested to the committee that it should not be recommended for pregnant women, arguing that “there is no clinical scenario where the benefits outweigh the risks” in this group.
While Merck’s clinical study did not include any pregnant women, the US Food and Drug Administration based its recommendation on the results of a study on pregnant mice and rabbits, in which some of the births had more abnormalities than other groups.
In order to request the license, Merck based this clinical trial that it and its partner, Ridgeback Biotherapeutics, conducted on people with mild to moderate cases of COVID-19 with at least one risk factor, who received treatment in the five days following symptoms. First.
The hospitalization or death rate for patients who received this treatment was 7.3% compared to 14.1% for those who received the placebo, while no deaths were recorded for people who were treated with “molnopiravir” compared to 8 in the placebo group.
In addition, the results were convincing enough that an independent data-monitoring committee, in consultation with the Food and Drug Administration, decided to stop the trial prematurely.
Antiviral drugs such as molnopiravir work by reducing the ability of the virus to multiply to suppress the disease. Its role can be twofold: that infected people do not suffer from serious symptoms, but also that those who have been in close contact with a patient do not develop the disease.