Takeda Pharmaceuticals, maker of Actos, tried to slip one past the Food and Drug Administration (FDA) again, but this time the Agency isn’t having it. Last week, the FDA denied approval for alogliptin, a drug created to take the place of Actos as Takeda’s number one diabetes drug, according to The Chicago Tribune.
This rejection announcement marks the second time that the Japanese drug giant has been shot down by the FDA for clearance of their new drug, which is already being marketed in Japan. The FDA denied approval for alogliptin the first time Takeda applied to license the drug in the United States in 2009. Both times, the regulatory board has sited insufficient data to support the safety of the drug.
Takeda Scrambles For Approval Before Actos Patent Ends
Although the FDA has warned that taking Actos over an extended period of time may be linked with an increased risk of bladder cancer, and trials in France were ominous enough to lead French regulators to pull the drug from the market entirely, the drug continues to be marketed in the United States.
Health-savvy diabetes patients may hope that Takeda’s development of a new diabetes drug to take the place of Actos was spawned by a desire to create a safer drug, but in fact, the real motivator seems to be money.
Actos’ patent is due to run out in four months, according to Bloomberg. At that time, other companies will be able to produce generic versions of the drug, which they will sell at a far cheaper cost, creating insurmountable competition for Takeda.
Thomas Harris, Takeda’s vice president of regulatory affairs said in a recent statement, “We will immediately request a meeting with the FDA to determine the appropriate next steps to take and are committed to addressing outstanding issues. We remain confident in the benefit that alogliptin with bring to patients with type 2 diabetes in the U.S., if approved.”
Patient Trust Broken
The jury is still out about whether alogliptin will represent a safer treatment choice for those suffering from diabetes. In the meantime, however, many patients feel a sense of growing mistrust, and even outrage about a system in which dishonest pharmaceutical companies are motivated by profits more than actually improving the health of their customers.
When deadlines to approve a brand new drug are created solely based upon concerns over a company’s expected drop in revenue, how is a patient to trust that thorough testing will be done to ensure the drug’s optimal efficacy, and to minimize risks? Most importantly, if a drug is quickly pushed through the approval process, how can patients trust that the drug won’t bear devastating long-term consequences, like Actos’ associated 40% increased risk of developing bladder cancer?
Where Do You Stand?
How do you feel about Takeda’s new, yet-to-be-approved diabetes drug? Are you hopeful that it will provide a safer alternative to Actos? Are you concerned about the company’s apparent rush to push their new drug through the approval process, despite grave side effects associated with their last diabetes medication? Is the FDA being too rigid in their approval process, or not rigid enough? Please share your thoughts and experiences in the comments section below, and forward this important news development on to friends and loved ones who suffer from diabetes and/or bladder cancer so that they can stay informed.