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Aprea’s Treatment For AML Gets Orphan Drug Status From EMEA

Aprea's treatment of acute myeloid leukemia (AML) has been recommended an orphan drug status by the The European Medicines Agency (EMEA). The treatment, at present, is subject to a Phase I clinical study and a final decision from the European Commission concerning the status is anticipated in some weeks.

Conny Bogentoft, CEO of Karolinska Development, said: “Aprea is developing a new class of anticancer drugs for the treatment of acute myelogenous leukemia, the most common acute leukemia affecting adults which is currently lacking efficient treatment.

“An orphan drug status would significantly shorten the development time, lower development costs and, if approved, extend market exclusivity to the benefit of affected patients, Aprea and Karolinska Development.”

Karolinska Development manages a portfolio of life science companies in Europe. Since 2003, it has built a portfolio of around 40 companies. Among the company’s projects, 12 compounds are undergoing clinical trials. The portfolio also includes a total of 19 other products.