Posted by Michael Wonder on 14 Nov 2017
Mereo receives EMA PRIME designation for BPS-804
13 November 2017 - BPS-804 to receive EMA ongoing advice with the potential for accelerated regulatory assessment in Europe.
Mereo BioPharma today announces that the EMA has granted BPS-804 PRIority MEdicines (PRIME) designation for the treatment of osteogenesis imperfecta (OI), or “brittle bone disease.” OI is a debilitating disease for which there is no current treatment approved by the U.S. FDA or the EMA. Mereo announced commencement of a Phase 2b trial for BPS-804 in adult patients with OI in May 2017.
The EMA PRIME programme provides early collaborative input to clinical development including scientific advice and health-technology-assessment in order to facilitate rapid access for patients to novel drugs in areas of high unmet medical need once they are approved. Since its inception in 2016, only 31 of 137 requests for PRIME have been granted. Under the PRIME programme, a marketing authorisation application (MAA) in Europe for BPS-804 for OI could be eligible for an accelerated regulatory assessment (150 days instead of 210 days).
