PRVB - Provention Bio provides regulatory update on teplizumab BLA

Provention Bio (PRVB) highlights potential delays in BLA approval timelines for its diabetes treatment teplizumab following pharmacokinetic ((PK)) comparability considerations raised by the U.S. FDA.The FDA reported that the PK profiles of the two drug products evaluated in the company's single, low-dose bridging study are not comparable, since the intended commercial product did not meet the pre-specified 80-125% PK area under the curve ((AUC)) comparability target range.The company said that a delay will depend upon the outcome of ongoing discussions with the FDA to find a solution, including potentially providing the agency reviewers with PK/PD data from the on-going Phase 3 PROTECT study in newly diagnosed patients.The health regulator also informed Provention that it plans to mention its PK comparability review in the clinical pharmacology summary of its briefing materials for the Advisory Committee meeting on May 27.

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Provention Bio provides regulatory update on teplizumab BLA