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news.Bristol-Myers Squibb has completed the submission of its supplemental biologics license application to the FDA for the licensure of a third-party manufacturing facility to support increased production capacity for its rheumatoid arthritis drug Orencia.
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If the company gets approval from the FDA, the third-party manufacturing facility will offer increased production capacity for the drug.
The FDA approved Orencia, the first selective modulator of a co-stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis (RA) on December 23, 2005.
Orencia is indicated for reducing the signs and symptoms of RA, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.