Questions are abounding about whether the US Food and Drug Administration should reconsider its stance on AstraZeneca’s clotbuster, Exanta (ximelagatran), after trial data suggested that the product is as effective as the current standard treatment, warfarin.
The UK giant suffered setback last September when a US Food and Drug Administration advisory panel knocked back the potential blockbuster in all three sought after indications, concluding that the drug’s liver toxicity outweighed its potential benefits as the first alternative to the decades-old warfarin [[13/09/04a]]. However, the results of the 3,922-patient study, which was published in the Journal of the American Medical Association, suggested that Exanta was as effective as warfarin in preventing strokes, and was associated with fewer bleeding side effects. Although the investigators recommended additional investigation to determine liver toxicity, Exanta was not associated with a statistically significant increase in stroke.
Although the Anglo-Swedish company has remained tight-lipped about the US future of Exanta, it is continuing to pursue additional labels in the European markets where it is already approved for preventing blood clots in patients undergoing hip and knee replacement surgery [[12/10/04b]].