Positive Avandia vote offers Glaxo little solace

Yesterday’s US FDA advisory panel vote to ease restrictions on GlaxoSmithKline’s troubled diabetes treatment Avandia came five years too late to make any difference to the UK company. The drug is now off patent, and Glaxo stopped supporting it years ago.

This is not about to change, and if the vote does result in broader availability of rosiglitazone, Avandia’s active ingredient, the main beneficiary will not be Glaxo but Teva Pharmaceutical, which has a generic version. More broadly, however, the move does send yet another message to the industry as to the agency’s willingness to approve more drugs and put behind it a period of extreme austerity.

The two-day panel had discussed a re-examination of the raw data in Avandia’s Record study – a cardiac outcomes trial in 4,447 type 2 diabetics (Upcoming events: June 3 – June 9, May 30, 2013). The re-examination had already confirmed the original analysis, showing no statistically significant differences between Avandia and active control for cardiovascular death, myocardial infarction or stroke.

A majority of the 26 panellists agreed, 13 voting to relax Avandia’s current risk-evaluation and mitigation strategy programme and seven to scrap it entirely. Of the remaining six panellists, five favoured the status quo and one voted to withdraw Avandia from the market entirely. The FDA itself has yet to make a final ruling.

Dr William Hiatt, from the University of Colorado, said Avandia did not look any different to any other diabetes drug. Not that this is exactly a ringing endorsement; diabetes medications are linked to a host of adverse events, and the FDA recently rejected Novo Nordisk’s long-acting insulins on cardiovascular concerns and is also scrutinising a link between incretin mimetics and pancreatic cancer.

Moreover, Avandia’s severest critic, Dr Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, was not on yesterday’s panel. It was Dr Nissen who had contributed most to curbing use of Avandia severely over the past seven years.

Once a blockbuster

The drug’s sales peaked in 2006 at $2.6bn, but the cardiovascular safety scare caused a marked revenue slump and, by the time restrictions were placed on its US label and EU marketing authorisation was withdrawn four years later, Avandia was finished. Last year’s sales amounted to barely $10m.

In a short statement yesterday Glaxo said it appreciated the panel’s examination, and said it would work with the FDA as the agency considers the recommendation. Still, the fact that it was not even Glaxo that had called for the review speaks volumes, and points to Teva and future potential generic filers as the real winners.

Industry watchers who had fretted over the huge dip in US drug approvals between 2005 and 2010, in the wake of Avandia and the withdrawal of Merck & Co’s Vioxx, will see any softening of the agency’s stance as positive. Already FDA approval rates have surged, and the agency sent none other than its commissioner, Margaret Hamburg, to Asco last week to promote its friendly stance towards truly efficacious medicines.

But for immediate beneficiaries like Teva, this at best signals only a modest enlargement of Avandia's tiny market.

Study Trial ID
Record NCT00379769

To contact the writer of this story email Jacob Plieth in London at jacobp@epvantage.com or follow @JacobEPVantage on Twitter

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