GSK salvages diabetes drug, for now

Even as the storm over heart risks posed by diabetes drug rosiglitazone continues unabated, drugmaker GSK Plc’s last-ditch effort at salvaging the blockbuster drug have borne fruit.

The US Food and Drug Administration (FDA) — the world’s foremost body monitoring drugs — is reviewing data from the clinical study on rosiglitazone by GSK, and once it completes the review, the agency will present an updated assessment of the risks and benefits of the drug at the joint public meeting of drug safety and risk management advisory committee in July 2010.
Meanwhile, patients taking the drug should continue unless told specifically by their healthcare professionals, said the FDA.

This study called Record (short for rosiglitazone evaluated for cardiovascular outcomes & regulation of glycemia in diabetes) was brought out by GSK in June 2009, and showed that the drug has no increased overall heart risks of either death or hospitalisation, compared to other commonly used diabetes drugs like metformin or sulfonylurea.

The study was done over a period of five and half years in 4,400 patients.

According to a diabetologist with a corporate hospital, the Record study is an attempt to convince stakeholders about the drug and the FDA reviewing it would help in mitigating the controversy for GSK.

According to a spokesperson from GSK Plc, the company has acted responsibly in conducting its clinical trial programme for rosiglitazone, in marketing the medicine, in monitoring its safety, and in updating information in the medicine’s labelling.

Rosiglitazone (brand name Avandia, sold as Windia in India) came out in 1999, and had annual sales of $3 billion in 2006, which dropped to $1.2 billion in 2009, after a 2007 study published in the New England Journal of Medicine that linked the drug to increased risk of heart attack.

The drug carries a black box warning (strongest warning) about its heart risks issued by the FDA in 2007.

Last Saturday, rosiglitazone faced fresh controversy with two American senators slamming GSK of being aware of possible heart risks before the evidence becoming public.

In the past the American Diabetes Association and the European Association for the Study of Diabetes have also advised against the use of the drug.

According to Ajay Ajmani, senior consultant, endocrinology, Dr B L K Memorial Hospital in New Delhi, the use of rosiglitazone has fallen since the controversy first erupted in 2007 and patients are being shifted to another drug — pioglitazone.

“We don’t use it on any patient,” says V Sarma, diabetologist, Fortis Hiranandani hospital, in Navi Mumbai.

However, patients taking it should not panic, says A K Jhingan, chairman of Delhi Diabetic Research Centre.

Indian players like Dr Reddy’s Laboratories, Sun Pharma, Glenmark, Orchid, Cipla, etc sell generic rosiglitazone in India, a nation of 41 million diabetics, where the market was the drug was estimated at Rs28 crore in 2009.