JANUVIA Approved in the European Union for the Treatment of Type 2 Diabetes

Merck & Co., Inc.JANUVIA™ (sitagliptin1), Merck & Co., Inc.'s once-a-day oral treatment for patients with type 2 diabetes, has been granted a license from the European Commission. JANUVIA now becomes the first and only medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance the body's own ability to lower blood sugar when it is elevated, to be adopted by the European Commission.

JANUVIA is indicated 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. For patients with type 2 diabetes in whom use of a PPAR-gamma agonist (i.e. a thiazolidinedione) is appropriate, JANUVIA is indicated in combination with the PPAR-gamma agonist when diet and exercise plus the PPAR-gamma agonist alone do not provide adequate glycemic control.

The adoption applies to all of the 27 countries that are members of the European Union (EU), including the United Kingdom, Germany, France, Italy and Spain, as well as Norway and Iceland (who follow European Medicines Evaluation Agency (EMEA) decisions). JANUVIA will be launched shortly in the EU countries. JANUVIA is now approved for use in 42 countries around the world including Mexico, the United States, and the Philippines.

In October 2006, the U.S. Food and Drug Administration (FDA) approved JANUVIA as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise are not enough. The recommended dose of JANUVIA is 100 mg once daily. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

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 greater 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).

About JANUVIA
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. JANUVIA is currently approved in at least one country in the major regions around the world including Asia Pacific, Europe, the United States and Latin America.

Sitagliptin 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 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.

Dosing of JANUVIA
The recommended dose of JANUVIA is 100 mg once daily, with or without food, for all approved indications. No dosage adjustment is needed for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl >50 mL/min). To achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency as well as in end-stage renal disease (ESRD) patients requiring hemodialysis. For patients with moderate renal insufficiency (CrCl >30 to <50 mL/min), the dose of JANUVIA is 50 mg once daily. For those with severe renal insufficiency (CrCl <30 mL/min) or with ESRD requiring dialysis, the dose of JANUVIA is 25 mg once daily. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter.

Use in specific populations
JANUVIA should be used during pregnancy only if clearly needed. Caution should be exercised when JANUVIA is administered to a nursing woman. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.

Expanding clinical trial program for JANUVIA
Merck's clinical development program for sitagliptin is robust and continues to expand with 47 studies completed or underway, and nine more studies set to begin this year. There are more than 7,600 patients in the Company's clinical studies with about 4,700 of these patients being treated with sitagliptin. Additionally, about 1,900 patients have been treated with sitagliptin for more than a year.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Most Popular Now

Scientists uncover SARS-CoV-2-specific T cell immu…

The study by scientists from Duke-NUS Medical School, in close collaboration with the National University of Singapore (NUS) Yong Loo Lin School of Medicine, Singapore Ge...

Common FDA-approved drug may effectively neutraliz…

A common drug, already approved by the Food and Drug Administration (FDA), may also be a powerful tool in fighting COVID-19, according to research published this week in ...

Drug linked to 45% lower risk of dying among COVID…

Critically ill COVID-19 patients who received a single dose of a drug that calms an overreacting immune system were 45% less likely to die overall, and more likely to be ...

GSK and CureVac announce strategic mRNA technology…

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialis...

Pfizer and BioNTech granted FDA Fast Track designa…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced that two of the companies' four investigational vaccine candidates from their BNT162 mRNA-bas...

Sanofi and Regeneron provide update on Kevzara® (s…

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical v...

Neutralizing antibodies isolated from COVID-19 pat…

Researchers at Columbia University Irving Medical Center have isolated antibodies from several COVID-19 patients that, to date, are among the most potent in neutralizing ...

Novartis launches first-of-its-kind not-for-profit…

Novartis announced a new initiative to help patients in low-income and lower-middle-income countries (LIC; LMIC) access affordable medicines to treat the major symptoms o...

COVID-19 vaccine AZD1222 showed robust immune resp…

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the SARS-Co...

Another mRNA-based vaccine candidate protects anim…

An experimental messenger RNA (mRNA)-based vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) elicits protective immune responses in mice and no...

Pfizer and BioNTech announce an agreement with U.S…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of...

Pfizer and BioNTech announce agreement with the Un…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candid...