Anvisa establishes contact with remdesivir manufacturer

Anvisa is in contact with Gilead, the company that manufactures remdesivir abroad, to follow up the studies for the treatment of Covid-19.  

Last Friday (May 1), the Food and Drug Administration (FDA) authorized the emergency use of the drug in the United States to treat the disease in hospitalized patients in serious condition. In the coming days, Anvisa will meet the manufacturer to check the interest and feasibility of supplying the drug to Brazil. 

Gilead has several clinical trials underway to test remdesivir, with initial data expected to be given in the coming weeks. If the benefit of the drug is proven, Anvisa has mechanisms, such as the approval to use it in health care programs or defining it a registration priority, to assure quick access of the medication.  

Gilead has not requested the registration of remdesivir in Brazil. There has also been no request for the approval of clinical research with the drug. We emphasize that only a clinical research aiming at the registration or change of registration, such as the inclusion of a new therapeutic use, for example, are within the scope of Anvisa's operations. Other kinds of research, such as scientific or academic studies, only require the approval by the Brazilian ethical bodies (National Ethics Commission and the Local Ethics Commissions).  

So far there has been no request for the authorization to use remdesivir in Assistance Programs through Expanded Access.