FDA approves B-MS sBLA for Orencia for third-party production

US drug major Bristol-Myers Squibb says that the Food and Drug Administration has approved a supplemental Biologics License Application for the licensure of Lonza Biologics, a third-party manufacturing facility, to support increased production capacity for Orencia (abatacept), enabling the company to meet expected long-term demand. This follows the late last year FDA approval of the drug, the first selective modulator of a co- stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis (Marketletter December 12, 2005).

Orencia is indicated for reducing signs and symptoms, 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, such as methotrexate or tumor necrosis factor antagonists.

The drug became available for initial commercial use in February 2006.