Pharma

FDA rejects diabetes drug alogliptin; Takeda gives few CRL details

Takeda Pharmaceutical’s (TYO:4502) diabetes drug alogliptin failed to secure U.S. Food and Drug Administration approval. […]

Takeda Pharmaceutical’s (TYO:4502) diabetes drug alogliptin failed to secure U.S. Food and Drug Administration approval.

The agency issued a complete response letter for new drug applications of alogliptin and a combination drug that pairs alogliptin with another Takeda drug, Actos.

“We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues,” Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center said in a statement. “We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved.”

The complete response letter is also a blow to Furiex Pharmaceuticals (NASDAQ:FURX), the company that licensed alogliptin to Takeda. The Morrisville, North Carolina company stood to gain a $25 million milestone payment upon FDA approval of the compound. But diabetes treatments have come under greater FDA scrutiny concerns about higher cardiovascular risks associated with the drugs.

Takeda did not disclose what concerns the FDA raised about the drug. But the company said the most common adverse events observed in phase 3 studies for alogliptin were headache, urinary tract infection, nasopharyngitis and upper respiratory tract infection. Adverse events reported in studies of the combination of alogliptin and Actos included nasopharyngitis, back pain urinary tract infection and influenza.

Alogliptin is already approved in Japan, where it is marketed under the name Nesina. The combination of Nesina and Actos is approved in Japan as a drug called Liovel. Takeda said that it recently provided postmarketing data from outside the United States and has been in discussion with the FDA. Takeda said the agency requested more data that the company believes it can supply from those postmarketing studies as well as from ongoing clinical research. A  Takeda cardiovascular outcomes study on the compound already under way is expected to have final results in 2014.

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