The Brazilian Health Regulatory Agency (Anvisa) approved, after a meeting on Wednesday, the emergency use of the drug molnupiravir, produced by U.S-based pharmaceutical company Merck Sharp & Dohme (MSD), effective against Covid-19.

MSD told Valor that the drug showed 89% efficacy against deaths in infected patients who started treatment up to five days after the onset of symptoms. The dosage for adult patients is 800 mg (four 200 mg capsules) to be taken orally, every 12 hours, for five days, with or without food.

In a statement, Anvisa said that molnupiravir is an oral antiviral drug that, in clinical trials, “showed beneficial effects in mild and moderate adult patients, with the ability to reduce hospitalizations and deaths.” For home use, it works to reduce the chances of the Sars-CoV-2 virus multiplying and reproducing in the body. In practice, the mechanism of action prevents the virus from replicating within the human body.

The drug has already been approved in the United States (by FDA), in Europe (EMA), in Japan, in the UK, in Australia, and also by the World Health Organization, and is in use in 17 countries. MSD told Valor that the drug is already being used in 30 countries.

According to the head of Anvisa, Meiruze Freitas, who was the rapporteur of the process and voted for its approval, it is important to have therapeutic options for certain clinical conditions, especially in individuals who are at high risk of developing the severe forms of Covid-19. The initial target audience, therefore, would be the elderly and people with comorbidities. Ms. Freitas, however, pointed out that molnupiravir is not a substitute for the Covid-19 vaccines, which remain the best option for preventing the disease.

According to Anvisa, the drug is for adult use, with sale on prescription, and is not recommended during pregnancy, breastfeeding, and for women who may become pregnant and who are not using effective contraceptives. Laboratory studies in animals, Anvisa said, have shown that high doses of molnupiravir can affect fetal growth and development. The agency also does not recommend use for more than five days in a row or preventive use. MSD, however, says it is conducting promising studies regarding prophylaxis with the drug, the results of which are expected to be published later this year.

In addition, the Oswaldo Cruz Foundation (Fiocruz) has signed a cooperation agreement with MSD to exclusively distribute molnupiravir to the Brazilian health care system (SUS) and perform the technological transfer of the drug.

According to Marco Krieger, Fiocruz’s vice president of Production and Innovation in Health, the agreement aims to take the drug to basic health units by the end of the first half – which depends on decisions by the Ministry of Health – and to advance in its reverse engineering, not only to have local production in the future, but also to explore the platform, with great potential for efficiency against other arboviruses infections, such as dengue and chikungunya. The agreement had been in the works for a year and two months and was signed Wednesday.

Source: Valor International

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