FDA accepts filed pre-market approval supplement to expand the indication for HYALGAN® (sodium hyaluronate) to include shoulder pain due to osteoarthritis
Bridgewater, NJ
September 20, 2005

The United States Food and Drug Administration (FDA) has accepted the filing of a Pre-Market Approval  (PMA) Supplement to expand the indication of Hyalgan® (sodium hyaluronate) to include treatment of shoulder pain due to osteoarthritis or osteoarthritis in association with rotator cuff tears and/or adhesive capsulitis in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen. Hyalgan® is currently indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen.  Sanofi-aventis is the sole distributor in the United States of Hyalgan, which is lincensed and manufactured by Fidia Farmaceutici of Italy.
 
About HYALGAN
HYALGAN is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, eg, acetaminophen.  HYALGAN is contraindicated in patients with known hypersensitivity to hyaluronate preparations.  Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site.

In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs. placebo was injection-site pain.

Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus.  However, the incidence of these events was similar in the HYALGAN and placebo groups.

In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. 

About Osteoarthritis of the Shoulder
Osteoarthritis is a degenerative disease that affects the joints. Osteoarthritis of the shoulder usually affects people over 50 years of age. 

According to the American Academy of Orthopaedic Surgeons, common symptoms of osteoarthritis of the shoulder include pain and limited range of motion, which are oftentimes aggravated by movement. 

According to the National Institute and Musculoskeletal and Skin Diseases (NIAMS), shoulder problems account for about 1.5 million visits to orthopaedic surgeon annually.

 

About sanofi-aventis

The sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

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Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

 

U.S. Contact

Amy Ba, +1 908-243-4261, amy.ba@sanofi-aventis.com