Takeda Pharmaceutical Co., Asia’s biggest drugmaker, failed to win clearance to sell its new diabetes treatment in the U.S., with regulators asking for more information on the use of the medicine in other countries.
The request came in a so-called complete response letter from the Food and Drug Administration, Osaka, Japan-based Takeda said in a statement today. The necessary data can be supplied from information collected outside the U.S. and from patient studies under way, the company said.
The rejection of the drug, known chemically as alogliptin, to treat type-2 diabetes, derails Takeda President Yasuchika Hasegawa’s plan for it to be a new revenue generator when its best-selling diabetes treatment Actos loses patent protection in four months. The application was initially rejected in 2009, when the FDA asked for more data on cardiovascular risks.
“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.”
Takeda rose 0.6 percent to close at 3,550 yen in Tokyo trading. The shares have lost half of their value in the past five years, partly because of drug development failures.
Annual sales of alogliptin will probably reach 150 billion yen ($1.8 billion) in five years, according to SMBC Nikko Securities Inc. Actos generated $4.5 billion in sales for Osaka, Japan-based Takeda last fiscal year, accounting for 27 percent of revenue.
The drugmaker initially applied to the FDA in December 2007 for approval to sell alogliptin. In June 2009, Takeda was told its clinical data was insufficient based on new guidelines on diabetes treatments and cardiovascular risks released in December 2008. Takeda conducted additional studies for its resubmission.
In the U.S., 25.8 million children and adults, or 8.3 percent of the population, have diabetes, including 7 million people who are undiagnosed, according to the American Diabetes Association’s Website. Cardiovascular disease and stroke are the complications patients can have as consequences of diabetes, the association said.
Diabetes is caused by the body’s inability to use or produce the hormone insulin. It can lead to heart disease, kidney failure, blindness or amputations. Most people have the Type 2 form linked to being overweight or inactive.
Alogliptin is approved in Japan and sold under the brand name of Nesina.