Januvia Gets EU Approval
Merck announced this week that Januvia has been recommended for approval in the European Union. The company said it has received a positive opinion from the Committee for Medicinal Products for Human Use -- part of the EU's European Medicines Evaluation Agency -- which recommended the first-in-class DPP-4 inhibitor be approved in Europe for type 2 diabetes. Merck also said it expects full marketing approval for Januvia in early April. The drug has already been approved for use in the United States and often EU approval is little more than a rubber stamp for decisions made stateside. In October 2006 the U.S. Food and Drug Administration cleared Januvia as a monotherapy and as add-on therapy to either metformin or thiazolidinediones to improve blood-sugar control in type 2 diabetes patients when diet and exercise are not enough.
Per Merck's Press Release:
The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of comprehensive data supporting the efficacy, safety and tolerability profile of JANUVIA. The submission package consisted of studies involving approximately 4,000 patients with type 2 diabetes treated with JANUVIA.
JANUVIA has been investigated in patients with type 2 diabetes to improve glycemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycemic control. JANUVIA has also been studied as add-on therapy with PPAR agonists in patients with type 2 diabetes in whom use of a PPAR agonist (e.g. a thiazolidinedione) is appropriate. In addition, it has been studied as monotherapy in many patients.
In clinical trials, JANUVIA demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with JANUVIA (>5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache. The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (2.3 percent; placebo, 2.1 percent), nausea (1.4 percent; placebo, 0.6 percent) and diarrhea (3.0 percent; placebo, 2.3 percent).
JANUVIA is an oral, once-daily, selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose. DPP-4 inhibitors enhance the body's own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.
Sitagliptin phosphate is also being investigated as part of Merck's single tablet combination with metformin, a widely prescribed medicine for type 2 diabetes. JANUMET is the proposed trademark for the combination tablet. The mechanism of action of DPP-4 inhibitors is distinct from that of metformin and other drugs in the currently available classes of glucose-lowering agents. JANUMET has been accepted for standard review by the FDA. FDA action is expected on the New Drug Application by the end of March 2007. The Company is also moving forward with regulatory filings in countries outside the United States.