EU follows U.S. with review of Glaxo AIDS drugs
LONDON, April 2 (Reuters) - The European Medicines Agency said on Wednesday it was seeking further information about the safety of certain GlaxoSmithKline Plc (GSK.L) AIDS drugs, after a study showed a higher heart-attack risk compared with other HIV medicines.
The move follows a similar review announced by the U.S. Food and Drug Administration last week.
The concern arises from a study of more than 33,000 patients that found those taking medicines containing the active ingredient abacavir had a greater chance of developing a heart attack.
"At present no changes to the prescribing information for abacavir-containing medicines are required, but further information is needed to determine the risk of myocardial infarction (heart attack) with abacavir-containing medicines," the watchdog said.
It is requesting data from ongoing epidemiological studies.
Abacavir is sold by Glaxo as under the brand name Ziagen, which had 2007 global sales of $218 million. The drug is also a component of Glaxo's Trizivir, Epzicom and Kivexa AIDS drugs, which had more than $1 billion in combined 2007 sales.
Glaxo said its own evaluation had not found that abacavir raised the chances of a heart attack.
Results of the study questioning the cardiovascular risk of the medicine were formally published on Wednesday in the Lancet medical journal.
The study found a similar but weaker association with heart attack risk with didanosine, sold as Videx by Bristol-Myers Squibb Co (BMY.N). (Reporting by Ben Hirschler; Editing by David Holmes)
