Anika Therapeutics said today it won CE Mark approval in the European Union for its Cingal drug-combo designed to treat osteoarthritis-related knee pain.
Cingal is a combined viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, a steroid used to treat inflammation, the Bedford, Mass.-based company said.
“The European approval of Cingal marks an important milestone for Anika as it advances our global expansion strategy, provides a platform for us to demonstrate our commercialization capabilities, and most importantly, reinforces the product’s tremendous clinical value to people struggling with the debilitating symptoms of osteoarthritis. We look forward to working with our distribution partners to commence our European launch in the coming months, while remaining steadfast in our commitment to collaborate with the FDA to bring this important treatment to the millions of Americans coping with chronic knee pain,” CEO Charles Sherwood said in a press release.
Anika said it plans to strenthen its global commercialization of its Cingal as well as bolstering its European launch through new and existing commercial partnerships.
“The availability of Cingal is welcome news for millions of Europeans living with osteoarthritis-related knee pain due to a lack of effective, long-lasting, non-surgical treatment options. Cingal combines 2 proven, approved therapies for pain and inflammation into a single injection treatment that has been shown to provide immediate pain relief that lasts for 6 months, reduce stiffness, and improve function. For knee pain sufferers, the availability of Cingal not only translates to postponing an invasive and costly knee replacement surgery, but also to enabling these individuals to resume their normal lifestyle prior to the onset of chronic pain,” Cingal phase III trial principal investigator Dr. Laszlo Hangody said in prepared remarks.
Anika said it previously won Health Canda approval for Cingal and is working to find a commercial partner to launch the device in the 2nd quarter of 2016.
Last December, Anika 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 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.