EMA calls for strengthened warnings for Iclusig

The European Medicines Agency has concluded its review of the benefits and risks of Iclusig (ponatinib), a treatment of leukemia, and has recommended strengthened warnings in the product information aimed at minimizing the risk of blood clots and blockages in the arteries.

USA-based Ariad Pharmaceuticals’ (Nasdaq: ARIA) Iclusig is  authorized in Europe for use in patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) who cannot take or tolerate several other medicines of the same class (known as ‘tyrosine-kinase inhibitors’). The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the drug’s initial authorization.

The drug is also approved in the USA, However, safety concerns led to sales of the drug in the USA being suspended briefly in November 2013. Iclusig was allowed back on the market nearly two months later, but restricted to a smaller group of patients.