The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis.
Although the application was filed under the accelerated approval pathway, the FDA said in its acceptance letter that Inovio did not submit adequate information to justify eligibility for the designation, according to a Dec. 29 company news release. The agency is continuing to review the application and has set a Prescription Drug User Fee Act goal date of Oct. 30, 2026.
Inovio plans to meet with the FDA to discuss how to maintain eligibility for the accelerated approval pathway and is not currently pursuing traditional approval for the therapy.
The application includes data from a phase 1/2 trial involving adults who had undergone two or more surgeries in the year before treatment. Follow-up data showed that most evaluable patients maintained clinical benefit during the second 12-month period after treatment without additional dosing.
