Provention will wait for FDA to ‘opine’ on new data after teplizumab rejection, eyes Q4 for further talks

Provention will wait for FDA to ‘opine’ on new data after teplizumab rejection, eyes Q4 for further talks

Provention Bio is being optimistic about the chances of resubmitting the rejected Type 1 diabetes asset teplizumab after the biotech’s shares took a battering on the FDA’s recent complete response letter.

After scraping through a tough advisory committee in March, the FDA returned a “no” verdict for approval of the therapy in July. Provention was gunning for an approval to help delay clinical Type 1 diabetes in at-risk individuals.

In the trial that underpinned the drug’s application, Provention said teplizumab delayed the onset of Type 1 diabetes by a median of two years. That delay could help patients avoid diabetic ketoacidosis, a life-threatening complication of diabetes.

Back in March, FDA experts assessing the drug raised concerns about how small the study was: It didn’t meet an enrollment goal and wound up testing teplizumab in just 44 patients. The committee also wondered about the fact that the study did not follow patients after their diabetes diagnosis.

The company submitted safety data from other trials of the drug in another indication, which the FDA reviewers noted were not a perfect comparison.

In July, the FDA asked for more data related to the drug product that was used in historical trials and the planned commercial product. The agency also asked for a “safety update” as part of the resubmission, though Provention gave no specifics here. The biotech expected to be able to offer the drug product data later this quarter from a sub-study underway in the ongoing phase 3 PROTECT trial in newly diagnosed Type 1 diabetes patients.

Monday, Provention gave an update on how all this was going. Data collection has finished up from the PROTECT sub-study, which is set up to find the comparability between teplizumab and the drug substance manufactured for historical trials.

Through ongoing discussions, the agency has now recommended that Provention request a formal Type A meeting to further discussions and submit briefing documents on the sub-study.

Provention is “working towards a request and submission” that could see this Type A meeting happen in the fourth quarter.

Additionally, the company disclosed preliminary data from the sub-study that the company believes “are supportive, although not determinative, of comparability between the two drug products.”

The FDA “has not yet opined on these data or their significance,” but Provention looks forward to discussing with the FDA.
“We believe we are making significant progress in our work to address the observations cited by the FDA in the CRL for teplizumab we received in July and we will continue to work with the sense of urgency that the patient community and our investors expect of us,” said Ashleigh Palmer, co-founder and CEO of Provention.

error: Content is protected !!