Anika Therapeutics has filed regulatory submissions in both the US and Europe seeking approval of Cingal, its hyaluronic acid/steroid jab for osteoarthritis of the knee.
Anika submitted its application for CE Mark approval to commercialise Cingal in the European Union and also filed a premarket approval application (PMA) with the US Food and Drug Administration to allow for marketing and distribution in the country.
Cingal is a single knee injection based on the same technology platform as Monovisc - which essentially functions as a joint lubricant to help alleviate pain - but with an added long-acting analgesic for extended pain relief.
The injection is backed by data from a 26-week, randomised, double-blind, Phase III placebo-controlled study, designed to evaluate the efficacy and safety of a single injection of Cingal in around 368 patients experiencing joint pain from osteoarthritis of the knee who had not responded to conservative treatment.
“The filing of these submissions is a milestone achievement for Anika and, after approvals, positions us extremely well in the market from a competitive standpoint,” said chief executive Charles Sherwood.