MSD Asks Anvisa To Authorize The Use Of Pill Against Covid-19 In Brazil


Covid-19: Manufactured by the American pharmaceutical company MSD in partnership with the biotechnology company Ridgeback Biotherapeutics, the first oral antiviral drug for covid-19 – molnupiravir – has just had its Emergency Use Authorization requested from the National Health Surveillance Agency (Anvisa) this Friday -Monday (26).

As we have already shown here at TecMundo in October, the phase 3 analysis of the drug study (multicenter, randomized, double-blind, placebo-controlled) revealed that, when administered at the onset of covid symptoms, molnupuravir is able to reduce by 50% of the chances of people in the risk group dying or needing hospitalization. The drug was also effective against the Gamma, Delta and Mu variants.

In a press release, the director of Regulatory Affairs at MSD in Brazil, Erika Machado, said: “We are confident that the results of the efficacy of molnupiravir, as well as technical and scientific information, will be sufficient to receive authorization from Anvisa and give us as much access as possible. before the Brazilian population.”

Understand Molnupuravir Tests

Phase 3 of the molnupuravir study began in April this year, and was carried out by administering the drug orally as a treatment to several outpatients with a confirmed diagnosis of covid-19 and up to five days of mild to moderate symptoms. The profile to participate in the trial required not having to be hospitalized, not having received any dose of the vaccine and having at least one type of comorbidity.

Conducted worldwide, the study included Brazilian patients from seven centers, two in São Paulo, and one in the cities of São José do Rio Preto (SP), Brasília (DF), Belo Horizonte (MG), Curitiba (PR) and Bento Gonçalves (RS). Completion of the survey, initially scheduled for November 2021, had to be brought forward to October 1 at the recommendation of an independent Data Monitoring Committee based on the good results.

To stop the study early, MSD first consulted with the US drug regulatory agency, the FDA, which is now reviewing the drug’s release in that country. Already with a favorable prior recommendation from the European regulatory agency EMA, the drug was approved for use in the UK on 4 November.