US FDA investigating stricken Ariad over Iclusig safety concerns

The US Food and Drug Administration is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking US drugmaker Ariad Pharmaceuticals’ (Nasdaq: ARIA) leukemia chemotherapy drug Iclusig (ponatinib).

Last week Ariad shares plunged a record 66% on October 9 after the FDA had placed a hold on enrollment of all trials of Iclusig, already cleared for marketing, because of safety issues among participants in ongoing studies. Iclusig was approved by the FDA last year to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

The FDA communication, issued on Friday, said: “Data from clinical trials and post-market adverse event reports show that serious adverse events have occurred in patients treated with Iclusig, including heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow. FDA is actively working to further evaluate these adverse events and will notify the public when more information is available.”