Anika Therapeutics today said the FDA’s Office of Combination Products assigned the company’s Cingal drug-combo to its Center for Drug Evaluation and Research arm to pursue premarket regulatory approval.
Cingal is a combined viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, a steroid used to treat inflammation, the company said.
“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. 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,” CEO Dr. Charles Sherwood said in a press release.
Cingal is being designed to relieve pain and restore joint function and aid in cartilage repair and regeneration, the company said. The company reported positive safety and efficacy results from clinical trials of single and repeat injections of Cingal.
Anika develops and produces Orthovisc and Monovisc as treatments for joint pain associated with osteoarthritis. Anika said Cingal is its 3rd generation viscosupplement product.
Cingal has won approval in Canada as a medical device to treat pain associated with osteoarthritis of the knee, and is currently under review in the European Union.
