* Alogliptin approved alone and in combinations
* Standalone to be sold as Nesina, combos as Kazano, Oseni
* Several postmarketing safety studies required by FDA
Jan 25 U.S. health regulators approved Takeda
Pharmaceutical Co's alogliptin to treat type 2
diabetes as a standalone drug and in two other formulations in
combination pills with older diabetes medicines.
The U.S. Food and Drug Administration announced the three
approvals simultaneously on Friday.
Alogliptin by itself will be sold under the brand name
Nesina, the agency said. The drug in combination with metformin
- one of the most common initial treatments for the disease -
will be sold as Kazano, and alogliptin along with pioglitazone -
the chemical name for Takeda's Actos - will be sold as Oseni,
the FDA said.
Type 2 diabetes is a growing health crisis that can lead to
numerous serious complications, such as heart disease,
circulatory problems and amputations, kidney damage, and
blindness. It affects about 24 million Americans and accounts
for more than 90 percent of diabetes cases diagnosed in the
United States, the FDA said.
Alogliptin, which lowers blood sugar levels by stimulating
the release of insulin after a meal, was shown to be safe and
effective in 14 clinical trials involving about 8,500 patients
with type 2 diabetes.
Due to caution about the heart safety of diabetes drugs
after GlaxoSmithKline's Avandia was shown to cause heart
problems, the FDA is requiring five postmarketing studies for
Nesina, including a cardiovascular outcomes trial to assure that
the drug does not increase of the risk of heart attacks or
strokes. Another study to be conducted once the drug is being
used by the public will monitor for liver abnormalities and
serious cases of pancreatitis.
Kazano's label will include a boxed warning for lactic
acidosis, a build-up of lactic acid in the bloodstream
associated with metformin use, the agency said.
The Oseni label will have a boxed warning for heart failure
associated with pioglitazone use. Pioglitazone belongs to the
same class of diabetes drugs as Avandia, known as
thiazolidinedione, or TZDs.