On July 14, 2014 ARIAD Pharmaceuticals reported that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has provided the Company with a request for limited additional information regarding Iclusig (ponatinib) as part of its ongoing review under the Article 20 referral procedure (Press release Ariad, JUL 14, 2014, View Source [SID:1234500626]). 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 patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD.

In March 2014 ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June.