Provention Bio has revealed that the U.S. FDA has uncovered “deficiencies” in the marketing application for the drugmaker's much-anticipated drug teplizumab for the prevention of type 1 diabetes.
The issues are concentrated around a bridging study which examined the pharmacokinetics of the teplizumab. The study evaluated the pharmacokinetic comparability of a final drug product originating from drug substance manufactured by AGC Biologics, which the Provention plans to use for commercialization, and a final drug product originating from a historic drug substance manufactured by Eli Lilly. The drug substance manufactured by Eli Lilly was the one used in the pivotal trial now supporting templizumab's approval.
The FDA indicated that based on the data it has reviewed to date, the PK profiles of the two drug products evaluated in the bridging study are not comparable.
Ultimately, these deficiencies mean that the discussion of labeling and post-marketing requirements can't happen yet — resulting in a significant delay in the FDA's review of the of BLA for the NJ-based biotech's lead investigational drug candidate.
The agency intends to conduct an Advisory Committee meeting on May 27 and says it will continue the review of clinical data submitted in Provention’s BLA application.
Read the press release