FDA Wants More Data on Novel Diabetes Drug
The FDA has asked for additional data before it can approve Takeda Pharmaceutical's novel selective dipeptidyl peptidase IV inhibitor (DPP-4i) alogliptin for marketing as monotherapy or as a combination pill with pioglitazone (Actos).
"We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues.
We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved," Thomas Harris, Takeda's vice president for regulatory affairs, said in a statement.
The company has already supplied the FDA with additional postmarketing data from patients treated outside the U.S., but the FDA is now asking for additional data from the company's clinical trial program, the statement noted.
According to the company, the drug is "designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide)."
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