Bristol-Myers Squibb files melanoma drug ipilimumab BLA; gets FDA priority review
The US Food and Drug Administration has accepted, for filing and review, drug major Bristol-Myers Squibb's (NYSE: BMY) Biologics License Application for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated.
The company also announced that the application has been granted a priority review designation by the FDA, meaning a six-month target for completing the assessment, and an action date of December 25. Despite what is positive news for the company, its stock dipped 0.7% to $26.40 in afternoon trading yesterday.
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.
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