The U.S. Food and Drug Administration (FDA) has extended its review period by three months for Provention Bio’s (NASDAQ:PRVB) Biologics License Application (BLA) for teplizumab in patients with type 1 diabetes.
The regulatory agency has set a new target action goal date of November 17, 2022.
FDA plans to communicate proposed labeling and any post-marketing requirement or commitment requests by October 17, 2022, if no major deficiencies are identified during the review period.
Ashleigh Palmer, Co-Founder and CEO, commented : “We are committed to collaborating closely with the Agency as it completes its review. We want to thank the FDA for its continued diligence as we continue to work towards bringing this potential first disease modifying therapy to patients with type 1 diabetes in the United States, for whom there is currently no approved treatment other than a life-time of exogenous insulin therapy."
The agency is requiring additional time for the review following an information request made earlier this month to be a major amendment to the resubmission.
Provention Bio shares closed trading up 2 percent at $4 on Thursday.
