FDA approves sNDA to update Flexion’s ZILRETTA® product label

Flexion Therapeutics, Inc., an American biopharmaceutical company, has reportedly announced that the United States Food and Drug Administration has awarded approval for the supplemental New Drug Application (sNDA) it filed to update the ZILRETTA product label for treating OA ( osteoarthritis) knee pain. Some of the key elements of the updated label include removal of language that states that the drug was not intended to be administered on repeat, inclusion of a study description and safety data from its Phase 3 repeat administration trial. Also incorporating data from nonclinical toxicology from previously submitted repeat and single administration studies conducted on non-diseased animals. Michael Clayman, M.D., CEO and President, Flexion, reportedly stated that the company is thrilled with the novel product label achieving the primary goal of eliminating unclear language regarding repeat administration, believed to be confusing to physicians, payers and patients alike. Clayman further stated that the company is also thrilled by the addition of safety data from its repeat administration trial as well as the elimination of the comparator statement that is inappropriate. The company believes that the updated label would support their goal of seeing ZILRETTA becoming on of the leading intra-articular therapy for osteoarthritis (OA) knee pain. John Richmond, M.D., Medical Director for Network Development, New England Baptist Hospital, reportedly stated that ZILRETTA is an immeasurable non-opioid option that can managing chronic OA-based knee pain and it is promising to see a novel product label that briefs clinical decision making. About Flexion Therapeutics: Flexion Therapeutics is a renowned biopharmaceutical company developing sustained release versions of existing drugs that are injected into the joint for the treatment of osteoarthritis. The company is focused on advancing innovative therapies for the treatment of patients suffering from musculoskeletal conditions. About ZILRETTA: ZILRETTA was given approval by FDA on October 6, 2017. It is the first and only intra-articular therapy for patients suffering from osteoarthritis knee pain. The Phase 3 trial showed significantly reduced knee pain for almost 12 weeks, with some patients experiencing pain relief through week 16. Source credit: https://ir.flexiontherapeutics.com/news-releases/news-release-details/flexion-therapeutics-announces-fda-approval-snda-revise