ARTICLE | Clinical News

Avandia rosiglitazone regulatory update

September 13, 2010 7:00 AM UTC

The U.K.'s MHRA said GlaxoSmithKline's Avandia rosiglitazone "no longer has a place" on the U.K. market after the agency's review of the diabetes drug that showed the risks outweighed its benefits. MHRA said it would wait for the final outcome of an ongoing safety review by the European Medicines Agency (EMA) to formally withdraw the drug. EMA's CHMP is expected to report a review this month. MHRA said it considers Actos pioglitazone, a diabetes drug from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan), to be a safe alternative to Avandia. In July, an FDA panel was split on whether to withdraw, restrict or allow wide use of Avandia (see BioCentury, July 19). ...