FDA Okays First DDP-4 Inhibitor for Type 2 Diabetes

ROCKVILLE, Md., Oct. 17 -- The FDA approved Januvia (sitagliptin) today, the first dipetidyl peptidase-4 (DDP-4) inhibitor, an oral agent for type 2 diabetes.

The agent was approved as monotherapy or in combination with Glucophage (metformin) or a peroxisome proliferator-activated receptor (PPAR) agonist, such as Actos (pioglitazone).or Avandia (rosiglitazone).

The price of once-daily Januvia, marketed by Merck, was not disclosed by press reports put it in the range of a pill. Another DDP-4 called Glavus, made by Novartis, is awaiting FDA approval.

Januvia was evaluated in a total of 2,719 patients with type 2 diabetes, in studies lasting from 12 weeks to more than a year, according to the FDA. These studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.

The most common side effects in clinical studies were upper respiratory tract infection, sore throat, and diarrhea.