Takeda Pharmaceutical Company’s new diabetes treatment was not approved for sale in the United States, as U.S. regulators asked for more information on the medicine than other countries.
The Food and Drug Administration requested information through a letter, according to Takeda. The company responded by stating that the necessary data can be supplied from information collected outside the U.S. and from patient studies already under way.
The drug, known chemically as alogliptin, is used to treat type-2 diabetes. The rejection of the drug slows down Takeda President Yasuchika Hasegawa’s plan for it to become the new revenue generator when Actos loses patent protection in four months. The initial rejection took place in 2009 when the FDA asked for more information on cardiovascular risks associated with use of the drug.
“We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues,” Thomas Harris, Takeda’s vice president of regulatory affairs, said in the statement. “We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved.”
Alogliptin is approved in Japan and is sold by the name of Nesina.
Actos is a prescription drug used to help improve blood sugar control in adults suffering from type 2 diabetes. Actos was designed to help the body make better use of the insulin it creates and to prevent the liver from making excess sugar.
Actos has been linked to an increased risk of bladder cancer. Anyone taking Actos for more than one year may face a 40% increase in the risk of developing bladder cancer.
If you or a loved one has experienced severe side effects from the use of Actos, you may qualify for compensation to help with the cost of your medical expenses as well as your pain and suffering. To contact an Actos lawyer for a free consultation and Actos lawsuit information, call Matthews and Associates toll free at 1-888-520-5202.