GlaxoSmithKline receives authorisation from EC for Avandia as oral monotherapy for treatment of type 2 diabetes

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GlaxoSmithKline receives authorisation from EC for Avandia as oral monotherapy for treatment of type 2 diabetes

London, September 2, 2003 - GlaxoSmithKline announced today it has received marketing authorisation from the European Commission for use of Avandia (rosiglitazone maleate) as oral monotherapy in type 2 diabetes patients, particularly overweight patients, for whom metformin is not a treatment option. Prior to this approval, Avandia was indicated for use in the European Union only as a combination therapy.

The new monotherapy indication for Avandia provides physicians with an effective therapeutic alternative to sulphonylureas for patients who are unable to tolerate metformin due to gastrointestinal side effects or patients with renal impairment where metformin is contraindicated.1 Unlike conventional therapy, Avandia, which belongs to the thiazolidinedione (TZD) class, targets the defects that underlie type 2 diabetes, namely, insulin resistance and beta-cell dysfunction.2-5

"This is a significant milestone for people with type 2 diabetes in Europe. Insulin resistance is not only a core defect of type 2 diabetes, but is also linked to the development of cardiovascular disease-- the leading cause of mortality in patients with type 2 diabetes. Therefore, addressing insulin resistance needs to be a main goal of disease treatment," said Stefano Del Prato, MD, professor of endocrinology and metabolism at The School of Medicine, University of Pisa, Italy. "Because Avandia targets insulin resistance, in patients for whom metformin is not an option, physicians now have a viable alternative to sulphonylureas. Avandia provides sustained glucose control. Good glucose control can help to reduce the risk of developing some long-term complications."

The European Commission also approved an amendment to the original combination indication for Avandia to align it with the monotherapy indication. The new label allows use in oral combination with metformin in individuals with insufficient glucose control despite maximal tolerated dose of metformin alone, particularly in overweight patients.

Avandia first received European approval for combination use in a defined patient population in 2000. Now approved for use in 96 countries worldwide, Avandia has been used to treat more than 4 million individuals with type 2 diabetes.

Safety Information

Avandia is now indicated in the European Union for use as monotherapy for patients who cannot take metformin (contraindication or intolerance), and in combination with metformin particularly in overweight patients, with insufficient glycaemic control despite maximal tolerated dose of metformin. Avandia is also indicated for use in combination with a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea who cannot take metformin (contraindication or intolerance).

In contrast to patients taking Avandia as monotherapy, patients taking Avandia with sulphonylureas may be at increased risk for low blood sugar.

Some people may experience anaemia or weight gain with Avandia.

Avandia may cause fluid retention or swelling which could lead to or worsen heart failure, so patients who experience this should tell their doctor. If patients experience an unusually rapid increase in weight, swelling or shortness of breath while taking Avandia, it's advised that they talk to their doctor immediately. Avandia is not for everyone. In Europe, Avandia may not be used for women who are nursing and/or pregnant or for patients with heart failure or active liver disease (identified by blood tests conducted before and during therapy).

Premenopausal, non-ovulating women are at increased risk of pregnancy following possible resumption of ovulation when taking Avandia and should consult their physician.

References:

1. Metformin (Hydrocholoride). Therapeutic Drugs, Colin Dollery 2nd Edition, M77- M81. Harcourt Brace, 1998.

2. Mayerson AB, Hundal RS, Dufour S, et al. The effects of rosiglitazone on insulin sensitivity, lipolysis, and hepatic and skeletal muscle triglyceride content in patients with Type 2 diabetes. Diabetes 2002; 51:797-802.

3. Carey DG, Cowin GJ, Galloway GJ, et al. Rosiglitazone increases insulin sensitivity and reduces factors associated with insulin resistance in Type 2 diabetics. Diabet Res Clin Prac 2000; 50(Suppl 1):P311.

4. Hallsten K, Virtanen KA, Lonnqvist F, et al. Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes. Diabetes 2002; 51:3479-3485.

5. Matthews DR, Bakst A, Weston WM, et al. Rosiglitazone decreases insulin resistance and improves beta-cell function in patients with Type 2 diabetes. GSK Enquiries UK Media Martin Sutton
David Mawdsley
Chris Hunter-Ward 020 8047 5502
020 8047 5502
020 8047 5502 US Media Nancy Pekarek
Mary Anne Rhyne
Patricia Seif (215) 751 7709
(919) 483 2839
(215) 751 7709 European Analyst/Investor Duncan Learmouth
Philip Thomson
Anita Kidgell 020 8047 5540
020 8047 5543
020 8047 5542 US Analyst/Investor Frank Murdolo
Tom Curry (215) 751 7002
(215) 751 5419

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