Provention Bio has won the go-ahead from the FDA to resubmit its application for a therapy to delay diabetes. The drug has been on hold since the agency questioned whether the planned commercial product was comparable to the product used in historical trials.
The New Jersey biotech said after market Thursday that it had resolved the comparability concerns with the FDA and teplizumab is clear for resubmission. The resubmission should be ready to go “in the first quarter,” the company said.
After discussions with the FDA, Provention agreed to use pharmacokinetic modeling to adjust the 14-day dosing regimen for the commercial product to match the exposure seen with material used in the treatment’s clinical trials. The company will propose a modified 14-day course to address the FDA’s concerns.
The resubmission will also include responses to the FDA’s questions about chemical, manufacturing and controls along with product quality considerations. The type A meeting was held in August last year.
Teplizumab is designed to help delay clinical Type 1 diabetes in at-risk people. The company found in clinical trials that the drug delayed onset of the disease by a median of two years, which can help patients avoid diabetic ketoacidosis, a life-threatening complication of diabetes.
The therapy narrowly passed the vote at an FDA advisory committee meeting in May last year amid questions about the small study size and more.
Provention had failed to meet its enrollment goal for the trial and ended up testing teplizumab in just 44 patients. The study also did not follow patients after their diabetes diagnosis. FDA reviewers also questioned the company’s submission of trials for other indications that were not considered a perfect comparison.
And then the FDA hit teplizumab with a complete response letter, rejecting the application. The agency questioned data related to the drug substance to be used in the commercial product and asked for a safety update in a resubmission.
RBC Capital Markets called the resubmission news “an early surprise,” which suggests “that teplizumab could still see the light of day in T1D delay.”
Teplizumab was granted a breakthrough-therapy designation by the FDA. The agency will have 30 days to review the resubmission to confirm whether it’s ready for full review. If accepted for review, the decision would be made within six months thanks to the breakthrough tag.
In the meantime, Provention is prepping for a potential teplizumab launch “with prudently gated spending and planning,” according to co-Founder and CEO Ashleigh Palmer.