FDA ADVISORY PANEL VOTES TO RECOMMEND ORENCIA FOR APPROVAL
The FDA's Arthritis Advisory Committee recently voted unanimously to recommend approval for Bristol-Myers Squibb's (BMS) rheumatoid arthritis (RA) drug candidate Orencia.
The panel's 7-0 vote came on the heels of an FDA analysis that determined Orencia (abatacept) is effective in treating patients with moderately to severely active RA. Orencia is a first-in-class selective co-stimulation modulator designed to inhibit the action of T-cells, which manage the autoimmune response that leads to joint inflammation often associated with RA.
Orencia's progress has been closely watched by financial analysts, many of whom predict the drug will eventually reach blockbuster status. Merrill Lynch's David Risinger said last week that sales of Orencia could top $1 billion by 2009. In February, ratings agency Standard & Poor's named Orencia one of its top 10 drug products to watch in 2005, noting the drug's performance is "critical in stemming the three-year slide in [BMS'] ratings."
BMS submitted its biologics license application (BLA) to the FDA for Orencia in March, and the original FDA action date was Oct. 1. However, the FDA has informed BMS it will require up to 90 additional days to complete the review of the abatacept BLA due to the complexity of the chemistry and manufacturing controls section of the application.