The Associated Press July 23, 2011, 12:16PM ET

FDA rejects new use for J&J immune disorder drug

Healthcare giant Johnson & Johnson plans to meet with U.S. regulators after they refused to approve a new use for the company's immune disorder drug, Simponi.

The company, based in New Brunswick, N.J., said Friday night that the Food and Drug Administration notified its Janssen Biotech Inc. subsidiary that it would not approve marketing of Simponi for limiting progression of structural damage in patients with moderate to severe rheumatoid arthritis.

In a statement, Janssen said it will request a meeting with the FDA to discuss the details of the decision and "future steps to achieve the intended approval."

Janssen applied for the approval in September 2010.

Simponi is a genetically engineered antibody drug that tracks down and binds up the protein TNF-alpha in the blood. In some people, the body produces excess levels of this protein, causing inflammation and damage to bones, cartilage and tissue.

Simponi was first approved in 2009 for sale in the U.S., Europe and Canada as a monthly injection for treating psoriatic arthritis, ankylosing spondylitis and, in combination with the drug methotrexate, for moderate to severe rheumatoid arthritis.

This year, the drug was approved in Europe and then Japan for slowing or preventing structural damage from rheumatoid arthritis in certain patients, uses similar to what the company is seeking in the U.S.

"We look forward to collaborating with the FDA to fully understand requirements needed to support" approval of the new use, Dr. Jerome A. Boscia of Johnson & Johnson Pharmaceutical Research & Development, said in a statement.

Johnson & Johnson shares revenue with Merck & Co. from Simponi and its predecessor drug, Remicade, which was approved in November 1999. Merck sells them in Europe, Russia and Turkey. J&J markets them in North, Central and South America, the Middle East, Africa and most of the Asia-Pacific region.

J&J reported Simponi revenue of $67 million in the second quarter and $162 million in the first half of the year. Remicade, which is approved for about a dozen uses in treating various immune disorders, brought J&J about $1.4 billion in the second quarter and $2.7 billion in the first six months of 2011.

Because Simponi suppresses part of the immune system, use can result in serious infections, including tuberculosis.

Other possible side effects, some of them rare, include: unusual cancers in children and teenagers, reactivation of the hepatitis B virus, heart failure, liver problems, bruising and bleeding easily, lupus-like symptoms such as shortness of breath and joint, muscle or chest pain, and nervous system problems such as multiple sclerosis.


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