Provention Bio thought the resubmission for its diabetes prevention drug teplizumab was in the clear. But now, the FDA needs more time for the application after getting a look at some new information.
The agency has extended its review by three months, possibly delaying a decision about teplizumab until Nov. 17.
The FDA told the company that a response to an information request it received has been considered a major amendment to Provention’s biologics license application resubmission, requiring more time to evaluate the drug, according to a June 30 after-market release. If the FDA doesn’t identify any major deficiencies, it plans to discuss proposed labeling and any postmarketing requirement or commitment requests with Provention by Oct. 17.
“We are committed to collaborating closely with the agency as it completes its review,” said Ashleigh Palmer, co-founder and CEO of Provention.
In January, Provention was given a green light from the FDA to resubmit the teplizumab application, which had been on hold as the agency questioned whether the planned commercial product was comparable to the product used in historical trials.
The New Jersey biotech said at the time that the comparability concerns had been resolved and resubmitted the application, which the FDA accepted in March.
Teplizumab was granted a breakthrough-therapy designation, meaning the FDA was expected to make a decision within six months compared to the typical 10.
The drug is designed to help delay clinical Type 1 diabetes in at-risk people. Provention found in clinical trials that teplizumab delayed disease onset by a median of two years, which can help patients avoid diabetic ketoacidosis, a life-threatening complication of diabetes.