Provention Bio, Inc.'s hopes of teplizumab becoming the first approved disease-modifying therapy for type 1 diabetes have hit the buffers after regulators in the US identified deficiencies in its submission for the closely-watched drug.
FDA Perturbed By Provention's Teplizumab Type 1 Diabetes Drug
Concerns Over Pharmacokinetics Data
The US regulator is worried about deficiencies in the submission for Provention Bio’s high-profile therapy teplizumab for the prevention of type 1 diabetes that could significantly delay its review.
