FDAnews Drug Daily Bulletin

EMA Launches Investigation Into Ariad’s Iclusig

Dec. 10, 2013

The European Medicines Agency (EMA) said Friday it is investigating Ariad’s leukemia drug Iclusig for the risk of blood clots, the same serious adverse event that prompted an FDA investigation and safety alert.

Despite FDA concerns that also led the agency to put a hold on all Iclusig (ponatinib) clinical trials and halt sales of the drug in the U.S., the EMA last month opted to allow the drug’s continued use under certain restrictions. 

At the request of the European Commission, the EMA says it has now launched an “in-depth review” of the benefits and risks of Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.

The EMA is investigating:

  • The nature, frequency and severity of events obstructing the arteries or veins;

  • The potential mechanism through which the medicine leads to these side effects; and

  • Whether there is a need to revise the drug’s recommended dose.

Iclusig, Ariad’s only commercial product, has been approved by the EMA and the FDA for adults with chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. — Melissa Winn

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