May 27 Quick Takes: EMDAC votes narrowly in favor of Provention’s teplizumab; plus BMS, Biohaven, Day One, Frazier, miRecule, Oisin and more

Ahead of teplizumab’s July 2 PDUFA date, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of approving the anti-CD3 mAb from Provention Bio Inc. (NASDAQ:PRVB) to delay Type I diabetes in at-risk individuals. The vote suggests a clearer path to approval than might have been expected a month ago, after Provention revealed that FDA identified deficiencies in its BLA that “preclude discussion of labeling and postmarketing requirements/commitments at this time” and that additional PK/PD data would be required, and subsequently recommended that the company remove “prevention” from its proposed indication. 

After generating efficacy on par with marketed biologics for ulcerative colitis, Bristol Myers Squibb Co. (NYSE:BMY) gained FDA approval for Zeposia ozanimod to treat moderate to severe active UC. BMS used a priority review voucher for the oral S1P receptor modulator, which is marketed for multiple sclerosis. ...