Bristol-Myers Squibb Announces that the U.S. Food and Drug Administration Has Extended the Review Timeline for the Ipilimumab Biologics License Application
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) 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 moved its decision date from December 25, 2010 to March 26, 2011.
In response to an FDA request, Bristol-Myers Squibb submitted further analysis of data pertaining to the current application for pre-treated advanced melanoma and the agency considers this to be a major amendment to the drug's BLA.
Bristol-Myers Squibb continues to be very encouraged by its interactions with the FDA and remains confident in the overall development program for ipilimumab. The company looks forward to continuing its close collaboration with the FDA on this application and addressing an important unmet medical need for patients with advanced melanoma. Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities worldwide for pre-treated advanced melanoma.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that ipilimumab will receive regulatory approval or, if approved, that it will be approved within the time frame described in this release or will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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