The U.S. Food and Drug Administration needs more time to review Flexion Therapeutics Inc.'s supplemental new drug application for Zilretta beyond the expected Oct. 14 decision date.
Zilretta was approved to treat osteoarthritis knee pain in 2017. The Burlington, Mass.-based biotechnology company has asked the FDA to revise Zilretta's label to include results from a Phase 3b clinical trial that evaluated repeated doses of the drug in patients with osteoarthritis knee pain.
The regulator did not provide a new date for the decision, but said the review is expected to be completed in the next few weeks, according to Flexion's Oct. 14 press release. Flexion also said the agency has not asked for any additional information to supplement the application.
Flexion develops anti-inflammatory and pain management therapies for patients with musculoskeletal conditions.