Mesoblast Limited announced that European Medicines Agency has approved expansion of their Phase 3 clinical program of its product candidate MPC-06-1D for degenerative disc disease.
Mesoblast’s Phase 3 program for this product candidate is currently in the process of enrolling patients in the United States under an Investigational New Drug (IND) application filed with the US Food and Drug Administration (FDA). Having received general agreement from EMA on the target patient population, trial size, primary composite endpoint, and comparators in the control population, Mesoblast now intends to additionally enroll patients across multiple European sites.
The discussions with EMA occurred as part of combined scientific and reimbursement advice under an EU pilot program known as Shaping European Early Dialogues (SEED). The SEED pilot program was established to facilitate early dialogue between EMA, European Health Technology Assessment reimbursement bodies, and selected companies with late-stage clinical development programs. Mesoblast’s product candidate MPC-06-ID is one of only seven medicines accepted for the SEED program.
Mesoblast and SEED representatives discussed key clinical trial aspects of the development of MPC-06-ID including the safety database, mechanisms of action, patient population and trial size, composite endpoints, and comparators. The discussions also focused on access to EU markets and pharmacoeconomic endpoints that may lead to reimbursement.
The guidance from the meeting with SEED representatives may result in a final comprehensive EU development and commercialization program that has an increased likelihood of producing data that will be acceptable for both registration and reimbursement review in multiple European countries.