Healthcare Industry News:  metformin 

Biopharmaceuticals Endocrinology Regulatory

 News Release - September 28, 2009

MSD Receives Positive CHMP Opinion for 'Januvia(R)' and 'Janumet(R)' as Add-On to Insulin in the European Union

WHITEHOUSE STATION, N.J., Sept. 28--(HSMN NewsFeed)--Merck & Co., Inc. (Whitehouse Station, N.J., U.S.A.), which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for ‘Januvia(R)’ (sitagliptin) and ‘Janumet(R)’ (fixed-dose combination of sitagliptin and metformin) recommending their use as add-on to insulin for the treatment of type 2 diabetes. If adopted by the European Commission, sitagliptin will be the only diabetes treatment in the DPP-4 inhibitor class to have an indication for use as add-on to insulin in the EU. The fixed dose combination of sitagliptin and metformin is not available in some EU countries, including the UK.

With this positive opinion, the CHMP recommends that sitagliptin alone or in combination with metformin be indicated as add-on to insulin when diet and exercise plus stable dosage of insulin and metformin alone do not provide adequate glycemic control.

“Sitagliptin is used by physicians worldwide in a variety of settings and we welcome the CHMP announcement as further evidence of the potential scope available with this treatment option for appropriate patients. As a company, Merck is committed to helping physicians and people with diabetes try to achieve target glycaemic levels and successfully manage their disease,” said Stefan Oschmann, president, Europe, Middle East, Africa and Canada, MSD.

Sitagliptin is a highly selective, once-daily DPP-4 inhibitor that enhances a natural body system called the incretin system to help regulate blood sugar by increasing levels of active GLP-1 and GIP hormones; it inhibits DPP-4 over 24 hours. The fixed-dose combination of sitagliptin and metformin targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, hepatic insulin resistance, and overproduction of glucose by the liver. Sitagliptin is the first approved medicine in the DPP-4 inhibitor class of oral treatments. It has been approved in more than 80 countries, and to date there have been more than 15 million prescriptions dispensed worldwide.

Recent regulatory milestones for sitagliptin

Sitagliptin has the broadest treatment range of all licensed DPP-4 inhibitors in the European Union, and is indicated for use in multiple settings and in combination therapy with a variety of other diabetes medications. Most recently, the European Commission approved restricted first line use of sitagliptin (or sitagliptin as monotherapy) to improve glycaemic control when diet and exercise alone do not provide adequate glycemic control and when metformin is inappropriate due to contraindications or intolerance. In addition, sitagliptin and the fixed-dose combination of sitagliptin and metformin were approved in June by the European Commission for use in combination with a PPAR? agonist and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. This is commonly referred to as 'triple' therapy.

About sitagliptin

When diet and exercise alone do not provide adequate glycaemic control and when metformin (as first-line therapy) is inappropriate due to contraindications or intolerance, sitagliptin is indicated to improve glycaemic control as monotherapy, in combination with metformin, in combination with a sulphonylurea, in combination with metformin and a sulphonylurea, in combination with a PPARy agonist, and in combination with a PPARy agonist and metformin. The recommended dose of sitagliptin is 100mg once daily, with or without food, for all approved indications.

Sitagliptin is contraindicated in patients who are hypersensitive to any component of this product. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Patients with moderate to severe renal insufficiency should not be treated with sitagliptin and it is not recommended in patients younger than 18 years of age or in women during pregnancy or breast feeding. When sitagliptin is added to a sulphonylurea, the incidence of hypoglycaemia was increased over placebo; to reduce this risk, a lower dose of the sulphonylurea may be considered.

Drug-related adverse events in excess (> 0.2 % and difference > 1 patient) of placebo has included nausea, hypoglycaemia, constipation, flatulence, peripheral edema, headache, diarrhoea, vomiting, and dizziness. Adverse events (regardless of causal relationship to medicinal product) occurring in at least 5 % and more commonly in patients treated with sitagliptin, included upper respiratory tract infection and nasopharyngitis.

About the fixed-dose combination of sitagliptin and metformin (‘Janumet(R)’)

‘Janumet’ is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. It is also indicated in combination with a sulphonylurea or a PPARy agonist as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea or a PPARy agonist, respectively.

‘Janumet’ is contraindicated in patients with hypersensitivity to any component of this product; diabetic ketoacidosis, diabetic pre-coma; moderate and severe renal impairment; acute conditions with the potential to alter renal function; acute or chronic disease which may cause tissue hypoxia; acute alcohol intoxication, alcoholism; pregnancy and lactation. ‘Janumet’ should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis. It should not be used in patients with moderate or severe renal impairment or in patients with hepatic impairment.

Drug related adverse reactions reported, in excess (> 0.2 % and difference > 1 patient) of placebo included nausea, hypoglycaemia, constipation, peripheral edema, headache, diarrhoea, and vomiting. Adverse events (regardless of causal relationship to medicinal product) occurring in at least 5 % included upper respiratory tract infection and nasopharyngitis. metformin adverse reactions included metallic taste, nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. Please find the complete product circular at http://www.emea.europa.eu.

About Merck, Sharp & Dohme

Merck & Co., Inc. (Whitehouse Station, N.J., U.S.A.), 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 programs that not only donate its 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.

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. Merck 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 Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

'Januvia(R)’ is a Registered Trademark of Merck & Co., Inc., Whitehouse Station, New Jersey, USA

'Janumet(R)’ is a Registered Trademark of Merck & Co., Inc., Whitehouse Station, New Jersey, USA


Source: Merck

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