Ariad to relaunch Iclusig in the U.S.

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) will resume U.S. marketing and distribution of Iclusig ponatinib by mid-January after FDA approved a REMS and a revised label limiting use of the leukemia drug. Ariad estimates 1,300 U.S. patients a year would be eligible for Iclusig under the narrower label, down from 2,500 under the previous label. In late October, Ariad shares tumbled $1.76 (43%) to $2.20 after the company said it would temporarily suspend U.S. marketing and distribution of Iclusig at FDA's request due to the risk of arterial thrombotic events (see BioCentury Extra, Oct. 31).

Iclusig is now indicated for chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) in patients who have the T315I variant of BCR-ABL tyrosine kinase or in patients for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated. Iclusig was previously approved for the indications in patients who were resistant or intolerant to prior TKI therapy. The boxed warning was revised to alert patients and healthcare professionals to the risk of vascular occlusive events and includes a new warning for heart failure. ...