Anika Therapeutics, a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (HA) technology, announced Health Canada approval of CINGAL as a medical device to treat pain associated with osteoarthritis (OA) of the knee.
CINGAL is the first and only approved combination viscosupplement formulated with the Company’s proprietary cross-linked sodium hyaluronate (currently marketed as the single-injection viscosupplement MONOVISC and triamcinolone hexacetonide, an FDA-approved steroid to treat inflammation.
"We are very pleased to announce the first regulatory approval for our breakthrough, next generation viscosupplement, CINGAL," said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "In its pivotal clinical study, CINGAL has demonstrated an ability to provide immediate and long-lasting pain relief for those affected by osteoarthritis of the knee.
"The availability of CINGAL allows us to extend the proven benefits of MONOVISC to a broader range of patients across the spectrum of osteoarthritis management. We look forward to advancing CINGAL through regulatory channels globally and improving the lives of millions of people worldwide struggling with the debilitating symptoms of osteoarthritis."
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.
Greater than 5% of the world’s population is afflicted by OA of the knee, making it the most common joint disease. Most commonly affecting middle-aged and older people, OA can range from very mild to very severe. Risk factors include being overweight, joint injury, muscle weakness, having other forms of arthritis, and heredity.
OA of the knee is characterized by the breakdown of cartilage, the part of the joint that cushions the ends of bones, which causes bones to rub against each other, and results in pain and loss of movement.
Degradation changes in the synovial fluid contained in the joint may also play a role in OA. Synovial fluid, which mostly consists of hyaluronan, lubricates the joint and is needed to facilitate movement of the joint.