U.S. advisers back Genzyme therapy for knee pain

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) - A U.S. advisory panel has unanimously backed a new version of a Genzyme Corp injection to relieve knee pain from osteoarthritis.

The panel of experts voted 5-0 on Tuesday to urge the Food and Drug Administration to approve Synvisc-One, a single-dose formulation of the company’s Synvisc injection. The FDA usually approves products that win panel endorsements.

The treatment is designed to provide up to six months of pain relief from osteoarthritis of the knee. The older Synvisc is given via three injections, each one week apart.

FDA reviewers said a Genzyme study showed a statistically significant reduction in pain but asked the panel if patients would feel a meaningful benefit.

“The panel agrees the device is modestly effective,” said panel chairman Jay Mabrey, an orthopedic surgeon at Baylor University Medical Center in Dallas.

A final FDA decision on the product is expected by December 23, Genzyme has said. An earlier ruling was delayed when the agency requested additional analyses and data in late 2007.

Synvisc-One contains a fluid made with hyaluronic acid extracted from chicken combs. Injecting the fluid is meant to lubricate and cushion the knee.

Other options to relieve pain from osteoarthritis include weight loss, exercise, over-the-counter and prescription painkillers, and knee replacement surgery.

Genzyme said patients needed an alternative, and the single injection of Synvisc-One was more convenient than a three-shot schedule. A company study of 253 patients showed a reduction in pain through 26 weeks.

Reports of potential side effects such as pain and swelling in the knee were similar with Synvisc-One and a saline injection, and were comparable to the original Synvisc, Genzyme said.

Synvisc-One already is sold in Europe and Asia. Synvisc products accounted for about $195 million of Genzyme’s $3.4 billion in total revenue through the first nine months of 2008.

Synvisc has been used to treat more than 5 million knees in the United States since its approval in 1997, Genzyme said. It is approved for patients who do not respond to conservative non-drug therapy and simple analgesics such as acetaminophen.

Competing products include Hyalgan from Sanofi-Aventis, Smith & Nephew’s Supartz, and Anika Therapeutics Inc’s Orthovisc, which is marketed by Johnson & Johnson unit DePuy Mitek in the United States.

Genzyme shares closed down 0.9 percent at $63.26 on Nasdaq after the panel vote, off their session low of $61.75.

(Reporting by Lisa Richwine; Editing by Tim Dobbyn)

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