FDA Panel Backs Provention Bio's Diabetes Drug Teplizumab

(RTTNews) - Provention Bio Inc. (PRVB) said that the U.S. Food and Drug Administration's Advisory Committee voted in favor of the benefits of teplizumab outweighing the risks in support of approval to delay clinical type 1 diabetes.

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA voted 10 to 7 in favor of teplizumab.

The Committee's recommendation was based on safety and efficacy data from the pivotal TN-10 Study in which a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 type 1 diabetes compared to placebo.

Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed Biologics License Application under Priority Review by the FDA for the delay of clinical T1D in at-risk individuals.

The FDA granted Breakthrough Therapy designation to teplizumab and priority review designation for the Biologics License Application (BLA). The Prescription Drug User Fee Act (PDUFA) action date is July 2, 2021.

The FDA will consider Committee's vote as it reviews the BLA, although it is not obligated to follow the Committee's recommendation. The previously disclosed matter surrounding Pharmacokinetic (PK) comparability was not a topic for discussion during the Advisory Committee meeting, Provention Bio said in a statement.

The company reiterated previous guidance that the FDA's Pharmacokinetic comparability considerations are likely to result in a delay in potential BLA approval timelines.