CHMP requests Ziagen data to assess heart risk

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) say that the available data do not allow a definitive conclusion on the cardic safety of UK drug major GlaxoSmithKline's Ziagen (abacavir).

Recent findings from analyses of the D:A:D study, a large observational trial of 33,347 HIV-1 infected patients in North America, Europe and Australia, led the US Food and Drug Administration to warn of possible increased risk of heart attack. Bristol-Myers Squibb's off-patent drug Videx (didanosine) was also implicated. The CHMP has asked for information from ongoing epidemiological studies to determine the risk. In a statement, the UK firm, which is the world's second largest R&D-based drugmaker by sales, said: "the D:A:D findings are surprising as we have not seen similar findings in our studies, and we are unaware of any potential biological mechanisms that could explain them. Abacavir is a component of a GSK HIV drugs franchise that inludes Kivexa and Trizivir, which saw sales of over $1.0 billion last year.