Ariad says PRAC requires additional data on Iclusig

US specialty pharma firm Ariad Pharmaceuticals (Nasdaq: ARIA) says that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has requested limited additional information regarding leukemia drug Iclusig (ponatinib) as part of its ongoing review under the Article 20 referral procedure.

The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following Ariad's response and input from the agency's Scientific Advisory Group, the company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use (CHMP) at its meeting in October 2014.

"As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML [chronic myeloid leukemia] patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig," said Timothy Clackson, president of R&D and chief scientific officer at Ariad.