No Letup for GSK: EMA Set to Review Rosiglitazone

July 12, 2010

July 12, 2010 (London, United Kingdom) — There is to be no calm before the storm of the two-day FDA advisory committee hearing on the cardiovascular safety of rosiglitazone (Avandia, GlaxoSmithKline)--the latest squall has blown in from the European Medicines Agency (EMA), which has announced that it, too, will look into the safety of the drug, starting at its plenary meeting next week, July 19–22 [1,2].

The EMA says it will review Avandia and two medicines containing rosiglitazone combined with other diabetes drugs: with metformin, marketed as Avandamet, and with glimepiride (Amaryl, Sanofi-Aventis), sold as Avaglim.

EMA spokesperson Monika Benstetter told heartwire that the fate of rosiglitazone in Europe may not be known until later in the summer or early autumn. "Nobody knows yet whether we will be finalizing this process next week; it may well be that it will carry on. It could be that we will have an opinion during the July Committee for Medicinal Products for Human Use [CHMP] meeting, but depending on the data, it may not be concluded."

She indicated, however, that any further evaluation would take weeks, rather than months. This would also allow the EMA to see how the FDA responds to its advisory committees' conclusions to be issued this week, she noted.

The EMA announcement came on Friday, the same day that nearly 1000 pages of documents were posted on the FDA website as briefing material for the safety hearing that starts in the US tomorrow. The bulk of the FDA material overwhelmingly points to an increased risk of adverse cardiovascular events with rosiglitazone over pioglitazone (Actos, Takeda Pharmaceuticals) and other diabetes drugs. But posted alongside these were data from the sponsor, which insists that it indicates that rosiglitazone has a positive risk/benefit profile and is "an important medicine for patients with type 2 diabetes."

EMA Options: Change, Suspend, or Revoke Authorization for Rosiglitazone

This latest EMA review of rosiglitazone was "triggered," said Benstetter, by the publication, two weeks ago, of two new papers: an observational study on rosiglitazone in Archives of Internal Medicine and a meta-analysis in the Journal of the American Medical Association.

In its press release, the EMA notes that at the time of authorization, Avandia, Avandamet, and Avaglim were contraindicated in patients with heart failure or a history of heart failure, and since then, the product information has been updated "to include warnings and contraindications on the use of these medicines in patients with heart problems."

The EMA last reviewed rosiglitazone earlier this year, when the CHMP issued a limited renewal of the marketing authorization for Avandia for a further five years, Benstetter said.

"Once all relevant data on the benefits and the risks of rosiglitazone have been looked at, the [EMA's] CHMP will issue an opinion on whether or not the marketing authorizations for these medicines should be revoked, suspended, or changed," its statement indicates.

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