Bristol-Myers Squibb's BLA for ipilimumab in melanoma delayed by US FDA

US drug major Bristol-Myers Squibb (NYSE: BMY) says that the Food and Drug Administration has determined that additional time is required to complete the review of the biologics license application (BLA) for ipilimumab in pre-treated advanced melanoma, and has pushed back its decision date by around three months from December 25, 2010 to March 26, 2011.

Ipilimumab was acquired by B-MS along with its $2.4 billion takeover of fellow USA-based Medarex in the fall of 2009, aimed at expanding the firm’s range of biological drugs and ahead of the patent expiry of the blockbuster blood thinner Plavix (clopidogrel), co-marketed with originator France’s Sanofi-Aventis.

In response to an FDA request, B-MS said it submitted further analysis of data relating to the current application for pre-treated advanced melanoma and the agency considers this to be a major amendment to the drug’s BLA.