PRVB - Provention Bio resubmits marketing application for diabetes drug in U.S.

The clinical-stage biopharmaceutical company, Provention Bio (NASDAQ:PRVB), is trading ~5% higher in the pre-market after the company announced the resubmission of its marketing application for experimental diabetes therapy teplizumab in the U.S. With the resubmission to the Food and Drug Administration (FDA), Provention Bio (PRVB) seeks regulatory clearance to market the drug in the U.S. for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. The FDA is expected to take 30 days to decide on the suitability and completion of BLA, and thereafter, announce a review goal date. The BLA resubmission followed the complete response letter (CRL) issued by the agency last July, indicating the need to address, among other things, the pharmacokinetic (PK) comparability considerations for the experimental therapy. The CRL did not flag any issues related to clinical efficacy and safety data in the original BLA submission, the company said. “We look forward to the FDA's review and

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Provention Bio resubmits marketing application for diabetes drug in U.S.