MOBIC Wins FDA Approval for Treatment of Rheumatoid Arthritis

Approval offers doctors an effective addition to the management of rheumatoid arthritis RIDGEFIELD, Conn., Aug. 9 /PRNewswire/ —

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the use of MOBIC® (meloxicam) tablets for the management and treatment of rheumatoid arthritis (RA). MOBIC is a nonsteroidal anti-inflammatory drug (NSAID) and has been available to patients in the U.S. since June 2000 for the relief of the signs and symptoms of osteoarthritis. This approval now offers the same relief to the approximately 2.1 million Americans suffering with rheumatoid arthritis.

Rheumatoid arthritis is a systemic disease that affects the entire body and is one of the most common forms of arthritis. "This FDA approval further underscores the efficacy and safety profile of MOBIC," said Paul Fonteyne, Executive Vice President, Head of Marketing and Sales Prescription Medicine. "Rheumatoid arthritis can be debilitating, and we hope this approval will enable many patients to find relief from the signs and symptoms associated with this disease."

The FDA approval follows a review of data from a placebo-controlled 12-week study of 1,184 patients with rheumatoid arthritis. Patients receiving MOBIC® (meloxicam) tablets at the recommended starting doses of 7.5 and 15 mg were more likely to complete the study than those receiving placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose. MOBIC is approved in the U.S. for the treatment of osteoarthritis and rheumatoid arthritis at the same starting doses. The starting and maintenance dose is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. Higher doses of MOBIC (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of MOBIC should not exceed 15 mg.

"Many of my osteoarthritis patients have found relief by using meloxicam (MOBIC)," said Dr. Peter T. Singleton (PM&R/Rheumatology), a Clinical Professor, Department of Orthopedic Surgery, Stanford University. "I have also seen the serious impact that rheumatoid arthritis can have on patients, and I'm pleased to be able to offer them an additional option for treating this painful disease."

About MOBIC® (meloxicam) tablets MOBIC is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis, and has been available in the U.S. since June 2000. MOBIC is contraindicated in patients who have experienced asthma, itching or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. As with all NSAIDs, serious GI toxicity such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine can occur at any time, without symptoms. As with other NSAIDs, MOBIC is not indicated for prevention of thromboembolic events and is not a substitute for aspirin or other drugs indicated for cardiovascular prophylaxis. MOBIC was developed by Boehringer Ingelheim and is co-marketed with Abbott Laboratories.

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About Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies. The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment Prescription Medicines on research and development.

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