Bangalore, June 1: Smithkline Beecham Pharmaceuticals India Ltd is planning to unveil its Avandia (rosiglitazone maleate), a drug for the treatment of type 2 diabetes in the country next year.The decision of the company comes close on the heels of SmithKline Beecham getting approval worldwide from the US Food and Drug Administration on May 25, 1999.
``The company is working on a launch strategy and we are in the process of approaching the local authorities for necessary approvals to unveil the product in the domestic market,'' SmithKline Beecham Pharmaceuticals India director N Ahmedali told The Financial Express.
The company would approach the health ministry for conducting clinical trials in Indian patients as a precursor to the launch. Avandia is an oral medication available in tablets which helps insulin to act better and ensure more sensitivity to tissues.
The company claimed that no drug is currently available in the country in this chemical segment and combination. Avandia is a newthiazolidinedione (TZD), an oral anti-diabetic agent that treats the symptoms of type 2 diabetes and directly targets insulin resistance - an underlying cause of the disease.
According to Ahmedali, type 2 diabetes (a section of diabetes which affects over a period of time in people) affects an estimated 15 million Americans and 110 million people worldwide and can lead to devastating complications like heart disease, blindness, kidney failure and limb amputation.
Avandia recently received marketing approval in Mexico. In addition, the product has been filed for regulatory approval with the European Medicines Evaluation Agency and in other 13 markets worldwide.
SmithKline Beecham has a co-promotion agreement with Bristol-Myres Squibb to promote these products worldwide.
A SmithKline Beecham official said this is an important advance in the treatment of type 2 diabetes and the new drug offers new hope for people living with this disease. Unlike most traditional diabetes drugs, Avandia helps the body'sown insulin work more effectively, resulting in significant blood sugar control.
A fundamental problem in type 2 diabetes is not a lack of insulin, but rather the body's failure to respond properly to its own insulin - known as insulin resistance.
Most older type 2 diabetes drugs work by enhancing insulin production in the pancreas or decreasing glucose output through the liver, whereas Avandia sensitises the body to use its own natural insulin more effectively, the company claimed.
Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.