Plymouth Meeting, PA-based INOVIO announced Wednesday it will be requesting an accelerated biological license application (BLA) from the U.S. Food and Drug Administration (FDA) this year.
The company said they have requested a rolling submission and priority review for its INO-3107 as a potential treatment for Recurrent Respiratory Papillomatosis (RRP). The announcement follows an Initial Comprehensive Multidisciplinary Breakthrough Therapy (Type B) meeting with the FDA on aspects of the data packaging the BLA requires under the agency’s accelerated approval program.
“Based on productive discussions with the FDA, we believe we now have established a path to submitting a BLA for INO-3107 under the accelerated approval program,” Dr. Jacqueline Shea, INOVIO president and CEO said. “Our plan is to complete the submission of our BLA in the second half of 2024 and request a Priority Review. We also plan to initiate a confirmatory trial prior to submission of our BLA. Concurrently, we will continue advancing our commercial plans, with the goal of being ready to launch INO-3107 in 2025.”
If granted, the priority review could shorten the preview process by an estimated six months from the time of submission being accepted, as compared to the standard 10 months. INOVIO said that if approved INO-3107 would be the first DNA medicine made available to RRP patients in the United States.