Following safety issues associated with Takeda's Actos and GlaxoSmithKline's Avandia, regulators and physicians will be on high alert for negative side effects from Bristol-Myers Squibb and AstraZeneca's new diabetes drug candidate dapagliflozin.
The compound is up for panel review next month, but analysts note that even if approved, doctors will be slow to prescribe the drug until more long-term safety data is available. Actos and Avandia were linked to cancer and heart problems, respectively. Both drugs work by controlling sugar-regulating hormones, while dapagliflozin blocks sugar from being absorbed.
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"Increasingly, people are on the lookout for problems with these drugs," Cleveland Clinic's Laurence Kennedy said in an interview with Bloomberg. "There will always be a market for finding newer and different ways to help control blood sugar, but the newest ways will be under increasing scrutiny."
Dapagliflozin is the first in a new class of drugs called SGLT2-inhibitors. Johnson & Johnson, Eli Lilly, Boehringer Ingelheim, Astellas Pharma, Isis Pharmaceuticals and Lexicon Pharmaceuticals are all developing drugs in this class, and all will be closely watching next month's FDA panel.
27 juin 2011
BMS, AZ diabetes drug will face scrutiny - FierceBiotech
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