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drug against cancer

Brazilian drug against cancer

Developed by Recepta Biopharma, the monoclonal antibody RebmAb 100, has received the designation of orphan drug for treating ovarian cancer from the Food and Drug Administration (FDA) of the United States. The status was granted on March 9 and is given to drugs that have shown to be potentially effective in fighting diseases with a relatively low incidence and that are of minor commercial interest. “This is the first time that a product developed by a Brazilian company has obtained this designation,” said José Fernando Perez, CEO of Recepta. “The attribution was based on an analysis of results obtained in our first phase 2 clinical trial, which treated patients with ovarian tumors that were resistant to chemotherapy.” 
The designation of orphan drug is not the same as approving the antibody for clinical use, but grants it some benefits, such as a faster approval process and the need for fewer patients in the phase 3 clinical trial. It also gives the right to a longer exclusivity period when the drug is eventually sold.