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.
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Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.
Rather than expose patients and others to SARS-CoV-2, Provention opted to pause a Phase III type 1 diabetes trial. Addex and Iveric have since delayed trial initiations and more studies are likely to be impacted as coronavirus concerns mount.