Glaxo drug cleared in the US

City A.M. Reporter
BRITISH pharmaceuticals giant GlaxoSmithKline got a boost last night as US health regulators said they would lift restrictions on the use of its once widely used diabetes drug Avandia after determining that it did not increase the risk of heart attacks.

The US Food and Drug Administration (FDA), following its review of a large clinical trial called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs.

These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement.

Avandia, which had been one of Glaxo’s top-selling medicines with sales of $3.2bn in 2006, was pulled from the market in Europe and had severe restrictions placed on its use in the US in 2010 due in part to ambiguity about a possible increased risk of heart attack and stroke seen in the Record study, as well as a review of other studies.

The drug was placed in a highly unfavourable light in 2007 after Dr Steven Nissen, head of cardiology at the Cleveland Clinic, reported results of a so-called meta-analysis in which data from 42 studies was pooled and analysed, showing a 43 per cent increased risk of heart attack from Avandia.

The UK-based drugmaker has previously said it is not likely to put its marketing muscle behind Avandia again, even if the FDA lifted the usage restrictions.