Expanded Labelling For Januvia(R) (Sitagliptin) Approved By European Commission
With this new approval for the two additional uses, the product is now indicated to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control, and when metformin is inappropriate due to contraindications or intolerance; and to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
Sitagliptin was approved in the European Union in March 2007 for the treatment of type 2 diabetes in combination with either metformin or, in certain patients, with a PPARγ agonist (i.e. thiazolidinedione) when diet and exercise plus either agent do not provide adequate glycaemic control. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
"The approval of these new indications is another step forward in helping to combat type 2 diabetes. It is important because it provides physicians and patients with more options to achieve reduced glycaemic levels," said Stefan Oschmann, President, Europe, Middle East, Africa and Canada, Merck & Co., Inc.
The approval of the indication extensions was based on phase III clinical trial results supporting the tolerability and efficacy of sitagliptin 100 mg once-daily in combination with glimepiride (a sulphonylurea) alone or with glimepiride plus metformin.1 Overall, the trial data showed that the addition of sitagliptin significantly reduced HbA1c levels and fasting plasma glucose levels, and was generally well tolerated.1
Januvia is a registered trademark of Merck & Co., Inc., of Whitehouse St, NJ, USA known in many countries as Merck Sharp & Dohme
In clinical trials in combination with a sulphonylurea (glimepiride), with or without metformin, sitagliptin demonstrated an overall incidence of adverse reactions higher than that seen with placebo, in part related to a higher incidence of hypoglycaemia with the treatment compared to placebo (12.2 percent vs. 1.8 percent, respectively). The higher rate of hypoglycaemia is commonly seen when antihyperglycaemic agents are used in combination with sulphonylurea agents. When sitagliptin is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
In controlled clinical studies in combination therapy with metformin or pioglitazone, the overall incidence of adverse reactions, hypoglycaemia, and discontinuation of therapy due to clinical adverse reactions with sitagliptin were similar to placebo. In these clinical studies, the most common adverse reactions reported (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.
Dosing of 'Januvia'
The recommended dose is 100 mg once daily, with or without food, for all adopted indications.
No dosage adjustment is needed for patients with mild to moderate hepatic insufficiency. The product has not been studied in patients with severe hepatic insufficiency. For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/min), no dosage adjustment is required. Clinical study experience in patients with moderate or severe renal insufficiency is limited. Therefore, use of sitagliptin is not recommended in this patient population.
No dosage adjustment is necessary based on age. Limited safety data are available in patients ≥75 years of age and care should be exercised.
No liver function tests need to be performed prior to the initiation of treatment.
Use in specific populations
Sitagliptin should not be used during pregnancy or during breast feeding. It is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.
Worldwide availability
The adoption of the indication extension will be applicable to the 27 countries that are members of the EU, including the United Kingdom, Germany, France, Italy and Spain. It is estimated that over 53 million people in Europe have diabetes.2 It has so far received approval in more than 60 countries and is available in every region around the world. As a result of this worldwide availability, there have been over three million prescriptions for sitagliptin.3
Expanding clinical development programme
Merck & Co., Inc.'s clinical development programme for sitagliptin is robust and continues to expand with 49 studies completed or underway and five more studies set to begin this year. There have been more than 9,400 patients in the Company's clinical studies, with about 6,000 of these patients being treated with the product. Additionally, about 2,300 patients have been treated with sitagliptin for more than one year and of these 400 patients have been treated for at least 2 years.
About Merck & Co., Inc., of Whitehouse Station, N.J., U.S.A.
Merck & Co., Inc. which operates in many countries as Merck Sharp & Dohme or MSD, is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, the Company 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 programme that not only donate its medicines but help deliver them to the people who need them. Merck & Co., Inc. also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.
Forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect MSD's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of MSD's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
Reference:
1. Hermansen K, Kipnes M, Luo E et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes, Obesity and Metabolism 2007 9(5):733-745.
2. International Diabetes Federation: Diabetes Atlas, 3rd ed. 2006 Chapter 1, p.28.
3. IMS Health, NPA™ Weekly, TRxs, week ending October 20, 2006 - week ending December 21, 2007.
http://www.merck.com
View drug information on Januvia.
Extinsã de etichetare pentru Januvia (R) (Sitagliptin), aprobat de Comisia Europeanã - Expanded Labelling For Januvia(R) (Sitagliptin) Approved By European Commission - articole medicale engleza - startsanatate