European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for CTI BioPharma’s pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia.
Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (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 authorization within three months. If authorized, pacritinib would be granted a marketing license valid in all 28 EU member states.
“The MAA validation is a significant milestone for CTI BioPharma as we seek to bring pacritinib to patients with myelofibrosis who have thrombocytopenia that could benefit from its unique profile,” said Adam R. Craig, M.D., Ph.D., President and CEO of CTI BioPharma.
The company noted that the MAA is primarily supported by data from two randomized Phase 3 clinical trials, PERSIST-1 and PERSIST-2, that evaluated pacritinib in patients with myelofibrosis.