Agios Withdraws European Tibsovo AML Submission

The move follows the drug’s failure to receive the endorsement of the EMA’s Committee for Medicinal Products for Human Use, which found that data from a phase 1 study did not demonstrate an acceptable level of efficacy.

Based on the same data, the FDA approved Tibsovo for the indication in 2018. In its approval, the agency noted that Tibsovo is “associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”

Although it is withdrawing its European application for the specific AML indication, the Cambridge, Mass., drugmaker said it will continue two ongoing phase 3 trials for newly diagnosed AML patients and plans to seek approval for that indication in the U.S. and EU.