Japanese drug maker Takeda Pharmaceutical is hoping to win Food and Drug Administration (FDA) approval for two diabetes drugs despite a highly publicized cancer risk with one of the drugs. Takeda announced that it is resubmitting its application for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Takeda’s type 2 diabetes drug Actos.

Takeda has been seeking FDA approval for alogliptin since 2009, when it was originally rejected because there was not enough information about potential cardiovascular risk. Takeda resubmitted its application only to have it rejected last May because the FDA wanted more information about the drug’s performance in other countries. The new application includes data from phase 3 clinical trials.

In August 2011, the FDA issued a warning that a 10-year clinical trial indicated that Actos significantly increased bladder cancer risk in patients who used the drug, compared to patients who were not treated with the medication. A new analysis, published in the July 3, 2020 issue of the Canadian Medical Association Journal found that people with type 2 diabetes are at increased risk for developing bladder cancer and that taking Actos increased that risk even more.

According to the study, the overall risk for patients on Actos of developing the disease was increased by about one-fifth. Long-term risk was even greater.

Takeda is eying alogliptin to help recover the expected sales lapse when the patent for Actos expires this summer. At that time, generic versions of Actos are expected to hit the market.

Source: DSN

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