Anika Therapeutics Announces Decision to Proceed with CINGAL® Premarket Review Through FDA’s Center for Drug Evaluation and Research
BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid technology, today announced that the U.S. Food & Drug Administration’s (FDA) Office of Combination Products has assigned CINGAL® to the Center for Drug Evaluation and Research (CDER) as the lead center for premarket review.
CINGAL is the first combination viscosupplement formulated with Anika’s proprietary cross-linked sodium hyaluronate (currently marketed as the single-injection viscosupplement MONOVISC®) and triamcinolone hexacetonide, an FDA-approved steroid to treat inflammation. Earlier this year, Anika announced positive results from its CINGAL 13-01 and 13-02 studies, demonstrating the efficacy and safety of a single injection of CINGAL for treatment of pain caused by osteoarthritis (OA) of the knee, as well as the safety of a repeat injection.
“While we strongly disagree with the FDA’s decision, as our position of CINGAL’s device-lead classification is supported by both regulations and scientific data, we intend to proceed expeditiously to move CINGAL through regulatory review,” said Dr. Charles H. Sherwood, President and Chief Executive Officer of Anika Therapeutics. “We have already been in contact with CDER to start the NDA process, and are confident that the definitive results from two clinical studies provide the essential foundation for marketing approval of CINGAL.”
CINGAL is Anika Therapeutics’ third-generation viscosupplementation product, adding to the Company’s strong product portfolio for the treatment of joint pain associated with OA. Anika already maintains a market leadership position in the United States and a growing presence internationally, with its multi-injection product, ORTHOVISC®, and its single-injection product, MONOVISC. CINGAL was approved in Canada as a medical device to treat pain associated with OA of the knee, and is under review in the E.U.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
