The FDA has sent a Complete Response Letter to Provention Bio for a drug developed to prevent type 1 diabetes in at-risk individuals.
In the CRL for Provention’s Biologics License Application for teplizumab, the agency said that the company failed to provide pharmacokinetic/pharmacodynamic (PK) comparability data for a study pitting the drug against an older treatment.
Provention said that additional data is being collected from an ongoing phase 3 trial and is being reviewed by a third party. If all looks good, the company indicated that it will submit the extra data to the FDA. Yet, the CRL sent shares for the company plummeting this week and could dramatically slow down the drug’s approval.
An analyst told Reuters this week that in the “best-case” scenario, the drug will be approved in a year — but if the FDA mandates another late-stage trial, Provention could spend several more years testing the drug.
The agency also recently had quality concerns with how the company is manufacturing teplizumab — an issue the company said it addressed in amendments to its BLA.
If approved, teplizumab could target a fairly large patient population in the U.S. alone where 1.6 million people have type 1 diabetes.
