PhaseBio’s PB2452 nabs accelerated review status in Europe

The European Medicines Agency has granted PRIME status to PhaseBio Pharmaceuticals’ (PHAS -2.1%) PB2452 as a reversal agent of AstraZeneca’s (AZN) anticoagulant Brilinta (ticagrelor).

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

The company says the advisory group CHMP has generally agreed to its proposed development plan for a non-randomized open-label Phase 3 study in major bleeding and urgent surgical populations, adding that positive results should be sufficient to support marketing applications in Europe and the U.S.

https://seekingalpha.com/news/3540602-phasebios-pb2452-nabs-accelerated-review-status-in-europe