Fiocruz to produce first oral antiviral against covid in Brazil

RIO DE JANEIRO, BRAZIL – On May 5, Farmanguinhos/Fiocruz (Pharmaceutical Technology Institute of the Oswaldo Cruz Foundation) announced a technological cooperation agreement with the US pharmaceutical company MSD (Merck Sharp & Dohme) to produce molnupiravir in Brazil, the first oral antiviral drug to treat covid-19.

The agreement was signed on May 3, and the drug received authorization for emergency use in Brazil from the National Health Surveillance Agency (Anvisa) on May 4. MSD filed the request to Anvisa in November.

At first, Fiocruz will be responsible for importing, administering, testing, storing, packaging, labeling, releasing, and supplying the drug to the Brazilian Unified Health System (SUS). The transfer of technology for 100% national production will be made possible over the next two years after assessing the technical conditions and SUS demand for molnupiravir.

The agreement establishes the conduction of clinical trials to verify the efficacy of possible prophylactic use for covid-19 and experimental studies of the drug’s activity against other viruses, such as dengue and chikungunya. MSD will monitor and assist in the partial transfer of technology activities.

According to the pharmaceutical company, molnupiravir “significantly” reduces hospitalizations and up to 89% of covid-19 mortality. Farmanguinhos director Jorge Mendonça explained that the agreement has been under discussion since early 2021. The negotiations resulted in a project with great potential for treating other diseases.

“We have been talking to MSD for more than a year and have been following the evolution of the tests and the results, hoping because we had a pandemic and a whole population to treat. I think we arrived at a very robust document, not only to bring one more tool to fight covid-19, but also to internalize the product and use it for other important diseases for SUS.”

ORAL ANTIVIRAL

Molnupiravir has already received conditional approval by the MHRA (Medicines and Healthcare Products Regulatory Agency of the United Kingdom) and the EMA (European Regulatory Agency), as well as approval for emergency use by the FDA (Food and Drug Administration, the U.S. regulatory agency). The antiviral is currently used in 17 countries.

According to Anvisa’s authorization, molnupiravir may be used to treat covid-19 patients over the age of 18, non-pregnant, who do not require supplemental oxygen and are at risk of progressing to the severe form of the disease, with the need for a doctor’s prescription.

The global phase 3 clinical trial, which began in April 2021, has seven centers in Brazil, three in São Paulo, one in Brasilia, one in Belo Horizonte, one in Curitiba, and another in Bento Gonçalves.

With information from Agência Brasil