RIDGEFIELD, Conn. and INDIANAPOLIS, June 24, 2011 /PRNewswire/
— Boehringer Ingelheim and Eli Lilly and Company (NYSE:
LLY) today received a positive opinion from the European
Medicines Agency’s (EMA) medicinal committee recommending approval
of linagliptin, 5 mg, film-coated tablets (to be marketed under the
trade name Trajenta® in Europe) for the treatment of adults
with type 2 diabetes. If adopted by the European Commission,
linagliptin will be the only DPP-4 inhibitor approved at one dosage
strength for patients with type 2 diabetes in Europe.
Linagliptin, 5 mg, is marketed under the trade name
Tradjenta™ (linagliptin) tablets in the U.S. and was approved
by the U.S. Food and Drug Administration (FDA) in May 2011 to be
used along with diet and exercise to lower blood sugar in adults
with type 2 diabetes. Linagliptin should not be used in
patients with type 1 diabetes or for the treatment of diabetic
ketoacidosis (increased ketones in the blood or urine). It has not
been studied in combination with insulin.
The Committee for Medicinal Products for Human Use (CHMP) has
recommended the approval of linagliptin as monotherapy in patients
inadequately controlled by diet and exercise alone and for whom
metformin is inappropriate due to intolerance, or contraindicated
due to renal impairment. Linagliptin is also recommended for
approval in combination with metformin and metformin plus
sulfonylurea. Data showed linagliptin plus metformin reduced
hemoglobin A1C (HbA1C or A1C) levels by a mean of 0.6 to 0.7
percent (compared to placebo). A1C is measured in people with
diabetes to provide an index of blood glucose control for the
previous two to three months. It is used as a marker to determine
the efficacy of glucose-lowering therapies.
“This will be an important step forward in the management of
type 2 diabetes in Europe,” said Prof. Anthony Ba
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