Takeda Pharmaceuticals has been dealt another setback in its quest to gain U.S. approval of its diabetes drug alogliptin and a combo tablet that combines the developmental compound with the blockbuster diabetes pill Actos. The FDA has delayed review of the drugs, moving the action date for the Japanese drugmaker's applications for approval from Jan. 25 to April 25, the company said today.
Tokyo-based Takeda has a lot riding on alogliptin, a DPP-4 inhibitor intended to help patients with type 2 diabetes manage blood glucose levels. The drug is a potential successor to Actos, the company's best-selling drug that loses patent protection next year. If the FDA stamps an approval on the combo of the two drugs, according to Takeda, it would be the first U.S. therapy to combine a DPP-4 inhibitor and a treatment from the thiazolidinedione class to which Actos belongs in a single tablet. Japanese regulators approved alogliptin (Nesina) and the alogliptin-Actos combo (Liovel) last year and in July, respectively.
Actos brought in $4.3 billion in global sales last year and accounted for 51.8% of Takeda's U.S. sales.
U.S. regulators have proven to be a tough bunch to win over for Takeda. They denied approval of alogliptin in 2009, demanding additional data on the drug amid concerns about cardiovascular risks to patients on the treatment. When the company filed for approval this summer, it was confident that interim results from an ongoing study into the cardiovascular risks would be enough to satisfy the FDA.
"Takeda is confident in alogliptin and alogliptin/pioglitazone [Actos] as potential therapeutic options for the millions of patients living with type 2 diabetes," Dr. David Recker, senior vice president of clinical science for Takeda Global Research & Development Center, said in a statement. "We will work closely with the FDA to determine the appropriate next steps, and are dedicated to continuing our efforts to bring these important therapies to market in the U.S."
- here the company's release
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