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FDA Approves Nesina, Kazano and Oseni Oral Medications to Treat Diabetes

Posted: Monday, February 04, 2013

After a long delay, the FDA approved the oral drug alogliptin (Nesina) for treatment of adults with type 2 diabetes, as well as two products combining alogliptin with other antidiabetic drugs.

Approved simultaneously with Nesina were alogliptin combinations with metformin (Kazano) and with pioglitazone (Oseni).

Alogliptin is the fourth dipeptidyl peptidase-4 inhibitor to win FDA approval, joining sitagliptin (Januvia), saxagliptin (Onglyza), and linagliptin (Tradjenta).

Drugmaker Takeda Pharmaceuticals America first applied for FDA approval in 2007, a year before the agency tightened its standards for new diabetes drugs. The agency then told the firm it would have to comply with those standards.

Although Takeda subsequently resubmitted its application with expanded data, the FDA twice more requested additional information, most recently last April.

As a monotherapy, alogliptin was studied in 14 trials involving some 8,500 patients, the FDA said. With a principal efficacy endpoint of glycated hemoglobin (HbA1c) level after 6 months, the drug reduced this marker by 0.4 to 0.6 percentage points relative to placebo, according to the agency.

As condition of the approval, Takeda will be required to do five postmarketing studies of Nesina, including one focusing on cardiovascular events as well as "an enhanced pharmacovigilance program" targeting liver abnormalities, pancreatitis, and hypersensitivity reactions.

The drugmaker was also ordered to conduct three pediatric studies of alogliptin: a dose-finding trial, a standard safety and efficacy study of the drug as monotherapy, and another such study of alogliptin combined with metformin.

The adult combination pill of alogliptin plus metformin was studied in four trials enrolling more than 2,500 patients. Compared with alogliptin alone, the combination reduced HbA1c levels by 1.1 percentage point after 6 months. With metformin monotherapy as the comparator, the combination reduced HbA1c by 0.5 points.

Similar results were seen in four trials of the alogliptin-pioglitazone combination pill with more than 1,500 patients. Compared with pioglitazone monotherapy, the combination reduced HbA1c at 6 months by 0.4 to 0.6 percentage points. Relative to alogliptin monotherapy, the reduction was 0.4 to 0.9 points.

Both combination products will have to undergo the same enhanced pharmacovigilance program as required for alogliptin monotherapy, the FDA said. The agency is also requiring a pediatric safety and efficacy study of the metformin-alogliptin pill.

Nesina, Oseni and Kazano were studied as monotherapies and also in combination with insulin and sulfonylureas. A monotherapy is a stand-alone therapy, one that is not given in combination with another drug.

These therapies should not be prescribed for patients with type 1 diabetes or people with diabetic ketoacidosis (high ketone urine levels).

Nesina is a DPP-4i (dipeptidyl peptidase-4 inhibitor). It is designed to slow down the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). Nesina (alogliptin) was shown to be both effective and safe in 14 human studies, which included 8,500 participants; all of them with type 2 diabetes: Patients on Nesina had reductions in HbA1c (glycosylated hemoglobin) of 0.4% to 0.6% compared to those on placebo after 26 weeks on the medication.

Kazano is a combination of alogliptin and metformin HCl, an extensively used anti-diabetes medication, in a single tablet. Kazano was shown to be both safe and effective in four clinical trials, which included over 2,500 participants, all of them with type 2 diabetes: Those on Kazano had additional reductions in HbA1c of 1.1% over Nesina, and 0.5% over metformin after being on therapy for 26 weeks.

Oseni, a combination of alogliptin and pioglitazone, is the first medication in the USA to include both a DPP-4i and a TZD (thiazolidinedione) in a single tablet. Oseni was shown to be both safe and effective in four clinical trials which included over 1,500 participants, all of them with type 2 diabetes: The patients on Oseni had additional reductions in HbA1c of 0.4% to 0.6% over pioglitazone alone, and 0.4% to 0.9% over alogliptin alone.

Common side effects with all three products included rhinitis, sore throat, and upper respiratory infection.


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