Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the Biologics License Application (BLA) to Nov. 17.
Provention Bio reported that the FDA said if no major deficiencies are identified during the review period, the regulatory agency will communicate the proposed labeling for teplizumab by Oct. 17. The FDA could also add post-marketing requirements or commitment requests, the company said.
The delay was prompted due to the company’s response to a request for more information regarding teplizumab data from the FDA.
The FDA initially set a review date of Aug. 17 for teplizumab, a drug that was previously rejected by the regulatory agency. The FDA issued a Complete Response Letter to Provention on July 2, 2021 that focused on a low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers.
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