Provention Bio gains PRIME designation for teplizumab from EMA

24 October 2019

Clinical-stage biotech Provention Bio (Nasdaq: PRVB) today announced the European Medicines Agency has granted PRV-031 (teplizumab) PRIority MEdicines (PRIME) designation for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease.

This adds to the similar Breakthrough Therapy designation from the US Food and Drug Administration for teplizumab issued in August, and with the EMA news pushing the company’s shares up 2.7% to $6.36 in early trading.

PRIME designation is awarded by the EMA to promising medicines that demonstrate the potential to address substantial unmet medical need based on clinical data. The EMA considers PRIME designations a priority and provides them with special support, including enhanced interactions and dialogue, as well as a pathway for accelerated evaluation and review.

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