FDA advisory committee recommends approval of MGA 031 for type 1 diabetes.- Provention Bio

The EMDAC based its recommendation 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 (T1D) compared to placebo. Acknowledging the significant unmet medical need facing early-stage T1D patients, the Committee Members discussed the strengths and limitations of the clinical data and provided opinions on the proposed indication statement and potential post-marketing studies. 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 the 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. The Company reiterates previous guidance that the FDA's PK comparability considerations are likely to result in a delay in potential BLA approval timelines.