In late 2015, FDA assigned Anika Therapeutics’ CINGAL® to the Center for Drug Evaluation and Research (CDER) and not the Center for Devices and Radiological Health (CDRH) for its premarket review—a decision with which Anika’s leadership says it disagrees.
CINGAL is the first combination viscosupplement formulated with Anika’s cross-linked sodium hyaluronate (currently marketed as single-injection MONOVISC®) and an FDA-approved steroid to treat inflammation. CINGAL was approved as a device to treat pain associated with knee osteoarthritis (OA) by Health Canada in November and is under CE Mark review as a device.
ORTHOWORLD queried Christopher Ranjitkar, Anika’s Investor Relations & Corporate Communications Manager, on whether the CDER announcement changes the way that the company will handle the product in the U.S.
ORTHOWORLD: What is the difference between the two review processes: drug vs. device? Is the drug pathway shorter than the device review?
Ranjitkar: Overall, drug reviews are more predictable than device reviews, as they follow a specific timeframe. Approval through the new drug application (NDA) pathway would set a high bar for CINGAL as the first HA drug, establishing a barrier to entry for potential competitors.
ORTHOWORLD: What, if any, effect has this pathway on Anika’s plans to market the product?
Ranjitkar: We believe CINGAL will successfully expand the viscosupplementation market. CINGAL can target patients outside of what is currently accepted to be the appropriate time for visco treatment in the OA spectrum. CINGAL is Anika Therapeutics’ third-generation viscosupplementation product, adding to a strong product portfolio for the treatment of joint pain associated with OA.
ORTHOWORLD: Why does Anika strongly feel that CINGAL should be classified as a device?
Ranjitkar: Our focus is to move CINGAL expeditiously through regulatory review to commercialization. We have been in contact with CDER to start the NDA process and expect to meet with CDER to finalize the content for an NDA submission in the coming weeks. CINGAL is approved in Canada as a medical device for the treatment of pain due to OA of the knee. It is under review in the EU as a medical device.
In announcing the CDER decision, Anika’s President and Chief Executive Officer, Charles H. Sherwood, M.D., said that regulations and scientific data supported CINGAL’s device-lead classification. Further, he said the company was confident that results from its two clinical studies would provide the data needed for a CDER approval.
In April 2015, Anika announced positive results from its CINGAL 13-01 and 13-02 studies, demonstrating the efficacy and safety of a single injection of CINGAL for treatment of pain caused by knee OA, as well as the safety of a repeat injection.
Also in the company’s pipeline is the hyaluronan-based scaffold HYALOFAST® with autologous bone marrow aspirate concentrate to treat articular knee cartilage defect lesions. Anika enrolled the first of ~200 patients at up to 30 U.S. and EU sites for a pivotal HYALOFAST FastTRACK Phase III clinical study in late 2015. Anika announced the filing of its Investigational Device Exemption with FDA for the trial in early 2Q15.