Posted by Michael Wonder on 16 Jul 2017
CTI BioPharma announces European Medicines Agency validation of pacritinib marketing authorisation application for patients with myelofibrosis who have thrombocytopenia
13 July 2017 - CTI BioPharma today announced that EMA has validated the marketing authorisation application for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microlitre).
Validation confirms that the submission is complete and initiates the centralized review process by the EMA's CHMP. The CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU authorisation within three months.
If authorised, pacritinib would be granted a marketing license valid in all 28 EU member states.
