Provention Bio’s BLA for Diabetes Drug Contains Data Deficiencies, FDA Says
The FDA has found deficiencies in the Biologics License Application (BLA) data submitted for Provention Bio’s teplizumab, a monoclonal antibody being reviewed for delaying or preventing type 1 diabetes, and the agency’s evaluation of it is likely to be delayed as a result, the company said.
Provention, a biopharma company based in Red Bank, N.J., said the agency found deficiencies in its BLA submission for teplizumab “that preclude discussion of labeling and postmarketing requirements/commitments at this time.”
The deficiencies, which will likely delay the agency’s decision on teplizumab, are not the only setback the drug has seen recently. The agency also alerted the company that, based on the pharmacokinetic/pharmacodynamic (PK/PD) trial data it has evaluated so far, it does not believe that the drug’s PK profile is comparable to the manufactured drug used by Eli Lilly when it was researching it more than a decade ago.