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FDA approves Johnson & Johnson rheumatoid arthritis drug golimumab

Annual sales of the medicine, to be sold under the brand name Simponi, are expected to exceed $1 billion. It is designed to be injected less often than Remicade, J&J's top-selling product.

April 25, 2009|Bloomberg News

Johnson & Johnson won U.S. approval of a rheumatoid arthritis drug designed to be injected less often than its top-selling product, Remicade.

The Food and Drug Administration on Friday announced its decision on the medicine, golimumab. The drug, to be co-marketed outside the U.S. by Schering-Plough Corp., will compete with Amgen Inc.'s Enbrel and Abbott Laboratories' Humira.

Remicade produced more than $5 billion in revenue last year, according to the data research firm IMS Health Inc. It was the leading medicine for Johnson & Johnson and Schering-Plough last year. Annual sales of golimumab, to be sold under the brand name Simponi, will exceed $1 billion, said Jeff Jonas, an analyst for Gabelli & Co. in Rye, N.Y.

Golimumab was also approved for use against ankylosing spondylitis, a progressive form of spinal arthritis, and psoriatic arthritis, a form of arthritis often associated with the skin condition psoriasis.

J&J, based in New Brunswick, N.J., will sell the drug in the U.S. Schering-Plough, of Kenilworth, N.J., will sell it in most other countries.

Shares of J&J fell 48 cents to $50.92. Schering-Plough gained 28 cents to $22.17.

The new product works by blocking TNF, or tumor necrosis factor, a germ-fighting protein that also can cause the inflammation found in rheumatoid arthritis patients.

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