Anika’s Knee Pain Product Gets FDA OK

The FDA has approved Anika Therapeutics’ Monovisc, a single injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients suffering from osteoarthritis (OA) of the knee.

Monovisc is the first single injection product with hyaluronate (HA) from a non-animal source to gain the agency’s approval, Anika said Tuesday. Monovisc’s clear, sterile fluid is composed of partially cross-linked sodium hyaluronate in phosphate buffered saline.

The product’s approval is based on positive data from a randomized, controlled, double-blind multi-center pivotal U.S. clinical study encompassing a total of 369 patients at 31 centers in the US and Canada suffering from OA of the knee.

The product is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics such as acetaminophen. Monovisc was designed to deliver a comparable HA dose to Anika’s three-injection viscosupplement Orthovisc in a single 4-mL intra-articular injection, the company says.

The U.S. market for viscosupplementation therapy is experiencing double digit growth annually and the approval of Monovisc better positions Anika with its single and multi-injection products, President and CEO Charles Sherwood said. — Johnathan Rickman

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