Monday, September 25, 2023
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The prevalence of type 2 diabetes in the United States is approximately 24 million, accounting for more than 90% of diabetes cases diagnosed. Alogliptin is a selective dipeptidyl peptidase IV inhibitor. The mechanism of action is to inhibit the inactivation of incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic peptide, which are involved in blood glucose regulation. The US Food and Drug Administration (FDA) had previously approved metformin hydrochloride and pioglitazone to manage type 2 diabetes.
The drug maker previously applied for FDA approval of alogliptin in July 2009, but this application was rejected because of insufficient cardiovascular data. In April 2012, the FDA requested further data regarding applications for alogliptin and the alogliptin/pioglitazone combination that was resubmitted in July 2011.
The FDA has approved 3 different formulations of the selective dipeptidyl peptidase-4 inhibitor alogliptin for the treatment of type 2 diabetes.
On January 25, the FDA announced approval of 3 drugs — Nesina (alogliptin) tablets, the fixed-dose combinations Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
Alogliptin is a selective dipeptidyl peptidase-4 inhibitor that works by slowing the inactivation of incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic peptide involved in regulating blood glucose levels.
The FDA had rejected the drug maker's previous application for alogliptin in July 2009, citing insufficient cardiovascular data. The company resubmitted applications for both alogliptin and the alogliptin/pioglitazone combination in July 2011, but in April 2012, the FDA requested further data.
The current approval is based on data from separate studies for all 3 formulations. Alogliptin monotherapy was studied in 14 clinical trials involving 8500 patients with type 2 diabetes, in whom it produced reductions in hemoglobin A1c (A1c) levels of 0.4 to 0.6 percentage points at 26 weeks compared with placebo.
The FDA is requiring 5 postmarketing studies for alogliptin, including 3 pediatric studies; a cardiovascular outcomes trial; and an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions.
The alogliptin/metformin combination was studied in 4 clinical trials involving over 2500 patients. It produced A1c reductions of 1.1 percentage points over alogliptin alone, and 0.5 percentage points over metformin at 26 weeks. As with metformin monotherapy, it will carry a black-box warning about the risk for lactic acidosis. Two postmarketing studies will be required for this formulation.
For alogliptin/pioglitazone, 4 clinical trials involving more than 1500 patients produced additional A1c reductions of 0.4 to 0.6 percentage points over pioglitazone monotherapy, and 0.4 to 0.9 percentage points over alogliptin alone. As with the other 2, the FDA is requiring enhanced pharmacovigilance for severe adverse events. And, as with pioglitazone, it will carry a black-box warning for heart failure.
Alogliptin will now be the fourth dipeptidyl peptidase-4 inhibitor licensed in the United States, but it was supposed to be the first. It was already far along in development in 2008 when the FDA issued new cardiovascular safety requirements for all new diabetes medications. This meant that the drug maker had to start fresh with new trials, while 3 competitors that were further back in development — sitagliptin, saxagliptin, and linagliptin — were able to beat alogliptin to market.
More information on these 3 new drug treatments for type 2 diabetes is available on the FDA Web site.
