FDA Approves Single-Injection Treatment for Pain of Knee OA
Decision comes 4 years after initial filing (February 25)
The FDA has granted marketing approval for Monovisc, a single-injection supplement to synovial fluid of the osteoarthritic joint designed to treat pain and to improve joint mobility in patients with osteoarthritis (OA) of the knee.
Monovisc is a sterile, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate-buffered saline. It is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, such as acetaminophen.
The FDA’s approval was based on positive data from a pivotal randomized, controlled, double-blind study of 369 patients with knee OA in the U.S. and Canada. The patients received either Monovisc or control (saline injection) and were evaluated for improvement in pain, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), at follow-up assessments out to 26 weeks.
According to a Reuters report, first filing for approval of Monovisc in December 2009 was rejected by the FDA on grounds that there were deficiencies in the application. The product’s developer (Anika Therapeutics) appealed the decision, but failed to win approval in December 2012, when the FDA upheld its decision. In January 2013, the company submitted an amended application, which has now been approved.