Provention Bio files for FDA approval on resurrected diabetes drug

Jan. 4, 2021

Provention Bio has filed an FDA marketing application for teplizumab, a humanized anti-CD3 monoclonal antibody, for the delay or prevention of clinical type 1 diabetes in at-risk individuals.

The FDA has granted a priority review for the diabetes drug with action date set at July 2, 2021. The company says if approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes.

The drug has a long history. Back in 2007, Eli Lilly and MacroGenics partnered to develop and commercialize teplizumab, well as other potential next generation anti-CD3 molecules for use in the treatment of autoimmune diseases. Then, in 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly and the drugmaker handed the rights back to MacroGenics. In 2018, the NJ-based startup — Provention Bio — in-licensed the drug from MacroGenics and used it as their lead drug for a $56 million IPO filing.

Since then,  teplizumab has shown value in preserving beta cells in the pancreas, reducing the need for insulin among Type 1 patients. New trial data announced last June show the drug delayed progression to clinical type 1 diabetes in high-risk participants, increased the average amount of time it takes for a patient to be diagnosed with type 1 diabetes to five years.

The FDA said it’s planning to hold an advisory committee meeting on May 27, 2021.

Read the press release