Ariad Pharma gets accelerated EU review for ponatinib

USA-based Ariad Pharmaceuticals (Nasdaq: ARIA) has filed a Marketing Authorization Application for its investigational BCR-ABL inhibitor, ponatinib, to the European Medicines Agency,  seeking approval for use of its drug in adult patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted Ariad’s request for accelerated assessment of the MAA. On July 30 this year, Ariad submitted a New Drug Application with the US Food and Drug Administration for the use of ponatinib in the same indication.

“The accelerated assessment granted to our MAA further illustrates the major unmet medical need among patients with CML and Ph+ ALL who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy,” stated Harvey Berger, chairman and chief executive of ARIAD, adding: “As we establish our European headquarters in Lausanne, Switzerland, and develop our commercial infrastructure in the region, our regulatory team will continue to work closely with the EMA as it reviews our data and the submission, potentially along an accelerated timeline.”