Takeda Pharmaceutical Co says that the European Commission has adopted the European Medicines Agency's view that the Japanese drugmaker's pioglitazone-based drugs, notably Actos, are still valid treatments for type 2 diabetes.
The move backs the EMA's Committee for Medical Products for Human Use opinion in October, which included label changes and clarification on the product indications for pioglitazone-containing medicines, eg Actos (pioglitazone) and Competact (pioglitazone/metformin). This concludes the European review which was initiated in March 2011 following the publication of data from a retrospective study which appears to indicate a slight increased risk of bladder cancer with the Takeda treatments.
Last summer, the CHMP concluded that pioglitazone-containing medicines remain a valid treatment option for certain patients with type 2 diabetes. While a small increased potential risk of bladder cancer has been associated in patients taking these drugs, the CHMP said this risk could be reduced by appropriate patient selection and updated contraindications and warnings in the product labels.
Takeda said it "continues to remain confident in the therapeutic benefits of pioglitazone as an important treatment for type 2 diabetes".
Mylan sued over generic Actos/metformin combo
Meantime, Takeda, Watson Pharmaceuticals and Andrx Labs have sued Mylan for patent infringement in connection with the latter's plans to market a generic version of Actoplus Met XR (pioglitazone/extended-release metformin).
In a statement, Mylan said it was the first to file "a substantially complete Abbreviated New Drug Application" to sell all strengths of the drug", thus qualifying for 180 days of marketing exclusivity upon final approval from the US Food and Drug Administration.