Please login to the form below

Not currently logged in
Email:
Password:

Avandia wins FDA reprieve

The FDA's advisory votes 22 to 1 in favour to keep GSK's troubled diabetes drug Avandia on the US market

The FDA's advisory committee has voted 22 to 1 in favour to keep UK-headquartered GlaxoSmithKline's (GSK) troubled diabetes drug Avandia (roseglitazone) on the US market.

On 30 July, GSK presented new data to Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

They voted that the data suggests some ischemic risk with Avandia, a treatment for type 2 diabetes. The committee declined to comment on comparative risk of Avandia with other oral anti-diabetic medicines, but nevertheless voted to keep the medicine available to patients in the US. The FDA will review the panel's recommendation before making a final decision.

"This was the first opportunity for these scientific experts to review the full data behind Avandia. The committee recognized the debilitating nature of this disease and the importance of multiple treatment options," said Dr Ronald Krall, GSKís CMO.

Concerns over Avandia were first raised in May 2007, when the New England Journal of Medicine (NEJM) published research claiming the treatment could increase the risk of heart attacks.

In the EU, both the European Medicines Agency (EMEA) and the UK's Medicines Healthcare Regulatory Agency (MHRA) are re-evaluating the drug's benefits in light of possible links with heart failure.

GSK has maintained its forecast for FY07 earnings per share growth of eight to 10 per cent following the panel's decision.

31st July 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Publicis Resolute

Publicis Resolute provides real-life practical solutions to your issues, without fuss or fluff. We are an experienced team with a...

Latest intelligence

Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...
NHS medicines optimisation milestone
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...

Infographics