MSD asks Anvisa for authorization for emergency use of drug against Covid

MSD said it has asked Anvisa (National Health Surveillance Agency) for emergency use authorization for its antiviral drug for Covid-19.

The drug, called molnupiravir, works by preventing the virus from replicating and has been shown to be clinically effective against variants such as Gamma, Delta and Mu.

“The results of the interim analysis of the phase 3 study (multicenter, randomized, double-blind, placebo-controlled) showed that molnupiravir significantly reduced the risk of hospitalization or death (primary study outcome),” the laboratory said in a statement. .

Known as Merck in the United States and Canada, MSD has been in advanced conversations with Fiocruz, since January 2021, to define a model of technical cooperation through its Pharmaceutical Technology Institute (Farmanguinhos/Fiocruz).

The ongoing negotiations between Fiocruz and MSD include the possibility of future studies to evaluate the antiviral in fighting other viral infections, such as dengue and chikungunya.

The drug, developed by MSD in collaboration with Ridgeback Biotherapeutics, already has UK approval and a favorable prior recommendation from the European Medicines Agency, the European Medicines Agency.

It has also been submitted by MSD to other regulatory agencies such as the FDA, EMA and the Japanese Pharmaceuticals and Medical Devices Agency.

MSD and Ridgeback conducted a clinical trial among approximately 770 patients. Of this universe, about half received a five-day pill treatment, and the rest a placebo.

All patients had Covid-19, with symptoms developing within five days of assignment to their respective groups.

Of the patients who received molnupiravir, 7.3% were hospitalized, compared with 14.1% of those who received placebo, representing a relative risk reduction of about 50%.

There were no deaths among those treated with molnupirvir, compared with eight in the second group. The results were convincing enough that an independent data oversight committee, in consultation with the FDA (the US food and drug industry regulator), decided to prematurely stop the study.