European reprieve for Takeda’s Actos
pharmafile | July 22, 2011 | News story | Sales and Marketing | Actos, diabetes
Takeda’s Actos is likely to remain on the market in Europe but regulators want the diabetes drug to carry stronger warnings after it was found to increase the risk of bladder cancer in some patients.
The EMA reviewed Actos (pioglitazone) and Takeda’s related brand Competact (pioglitazone and metformin) after French and German authorities pulled the drug from their countries last month.
It concluded Actos provides a ‘vital treatment’ for type II diabetics looking to reduce their sugar levels and will pass its recommendations to the European Commission, who will most likely adopt the same position.
The new warnings advise prescribers not to use Actos or Competact in patients with bladder cancer or a history of the disease, or in patients with uninvestigated macroscopic haematuria.
The EMA said risk factors for bladder cancer should also be assessed before starting pioglitazone treatment and it wants doctors to review patients on the drug after three to six months (and then regularly afterwards).
European regulatory advisers at the CHMP said Actos’ risks could be reduced by appropriate patient selection and exclusion, including a periodic review of the efficacy and safety of the individual patient’s treatment.
Takeda said it would work with the EMA, adding it was “committed to patient safety, […] as a company we continuously monitor the safety and tolerability of all of our products”.
The new warning comes after several studies indicated a small increase in the risk of bladder cancer in some patients.
A US regulatory review of the drug is currently underway by the FDA, which could also lead to further warnings or restrictions for Actos and Competact in the world’s largest pharma market.
Actos is currently Takeda’s best-selling product, bringing in Y387.9 billion ($4.83 billion) last year, but is soon to go off patent, meaning any loss in revenue from these decisions will not hit the company too hard.
The EMA’s recommendation is independent from the actions taken by the French and German regulatory agencies, where the drug remains unavailable – Takeda said it was “dedicated to working closely with these regulatory agencies on appropriate next steps within each country”.
It’s been a bad time for antidiabetics, after GSK’s Avandia was pulled from the EU market and heavily restricted in the US after heart attack fears last year.
More recently, an FDA panel voted against the use of Bristol-Myers Squibb and AstraZeneca’s unlicenced diabetes drug dapagliflozin, saying they needed more information on its safety before the drug should be licensed.
Ben Adams
Related Content
CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for …
Roche shares data on novel solution for continuous glucose monitoring
Roche has shared the latest data on its novel solution for continuous glucose monitoring (CGM), …
Novo Nordisk shares positive results from COMBINE 3 phase 3a trial
Novo Nordisk has shared topline results from the COMBINE 3 phase 3a trial of once-weeklly …
