Anika Therapeutics obtains CE mark for Cingal to treat OA knee pain

Issue: March 2016

Anika Therapeutics Inc. announced it has received CE mark approval for Cingal, reportedly the first and only commercially available combination viscosupplement formulated with triamcinolone hexacetonide and the company’s proprietary crosslinked sodium hyaluronate.

The CE mark was issued for Cingal as a medical device to treat pain associated with osteoarthritis (OA) of the knee. The product is administered via injection into the knee, according to a company press release.

The crosslinked sodium hyaluronate used in the product is currently marketed as the single-injection viscosupplement Monovisc, according to the release, and triamcinolone hexacetonide is a well-established, FDA-approved steroid used to treat inflammation.

“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,” Charles H. Sherwood, PhD, president and chief executive officer of Anika Therapeutics, stated in the release. “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.”

Anika recently announced plans to strengthen its global commercialization capabilities, and the company will support key aspects of the European launch, which will be executed through a network of new and existing commercial partnerships. The company previously achieved approval of Cingal in Canada. The company is working with its distribution partner there to finalize the commercial launch of the product in the second quarter of 2016.