Actos pioglitazone regulatory update

EMA's CHMP recommended updating the label for Actos pioglitazone from Takeda to include additional warnings about the risk of bladder cancer, but did not recommend withdrawing the diabetes drug. While the committee concluded there is a small increased risk for bladder cancer, it said Actos remains a valid treatment option for certain Type II diabetics who can't be adequately treated with other drugs. CHMP did ask Takeda to conduct a pan-European epidemiological study focusing on the characterization of the risk of bladder cancer in patients taking Actos. CHMP also recommended updating Actos' label to include contraindications and warnings regarding appropriate patient selection and exclusion, along with a periodic review of the efficacy and safety of the patient's treatment.

The decision to keep Actos on the market follows divergent decisions on the drug last month by regulatory agencies in France, Germany and the U.S. after a French retrospective study of about 1.5 million diabetics showed a significantly increased risk of bladder cancer in patients receiving Actos compared with patients given other diabetes drugs. Based on the results of the French study, the French Medicines Agency suspended the use of Actos and the German Federal Institute for Drugs and Medical Devices (BfArM) recommended against the drug's use. Takeda subsequently withdrew the thiazolidinedione (TZD) peroxisome proliferation activated receptor (PPAR) gamma agonist insulin sensitizer in France (see BioCentury, June 13; June 27 & July 18). Meanwhile, FDA said it is updating Actos' label to warn that use of the drug for >1 year may be associated with an increased risk of bladder cancer (see BioCentury, June 20). ...