US-based Anika Therapeutics has received CE mark approval for Cingal to treat pain associated with osteoarthritis of the knee.
Cingal is claimed to be the first and only commercially-available combination viscosupplement, which was formulated with the firm’s cross-linked sodium hyaluronate and triamcinolone hexacetonide.
Sodium hyaluronate is currently marketed as the single-injection viscosupplement Monovisc, while triamcinolone hexacetonide is the FDA-approved steroid to treat inflammation.
Anika Therapeutics president and CEO Charles Sherwood 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."
Earlier, the company also obtained approval for Cingal in Canada, and is currently working with its distribution partner to commercially introduce the product in the second quarter of this year.
Anika said it also continues to vigorously pursue regulatory approval of the product in the US.
Cingal is the company’s third-generation viscosupplement, following the Orthovisc and Monovisc products for the treatment of pain associated with osteoarthritis of the knee.
Image: Histopathology of osteoarthrosis of a knee joint in an elderly female. Photo: courtesy of KGH.