ARIAD Pharma: PRAC Recommends No Change To Approved Indication For Iclusig

(RTTNews) - ARIAD Pharmaceuticals Inc. (ARIA) announced that the Pharmacovigilance Risk Assessment Committee, or PRAC, of the European Medicines Agency has concluded its review of Iclusig (ponatinib), and has recommended that Iclusig continue to be used in Europe in accordance with its already approved indications.

The company reported that the recommendations made by the PRAC related to the Iclusig Summary of Medicinal Product Characteristics include: patient monitoring for response according to standard clinical guidelines; consideration of Iclusig dose-reduction following achievement of major cytogenetic response with subsequent monitoring of response and; consideration of Iclusig discontinuation if a complete haematologic response has not been achieved by three months.

The PRAC is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. The PRAC's recommendations are considered by the CHMP when it adopts opinions for centrally authorized medicines and referral procedures. ARIAD expects adoption of the recommendations by the CHMP later in October, and authorization by the European Commission by the end of the year.