Safety scare spells the end for Exanta
pharmafile | February 15, 2006 | News story | Sales and Marketing |Â Â Â
AstraZeneca is to abandon its novel anti-blood clotting drug Exanta after concerns emerged about its long-term safety.
Just two years ago, Exanta looked set to be one of the company's 'megabrands', promising to replace warfarin and other older blood-thinning products with its simpler and more convenient oral treatment with fewer side effects.
Then in September 2004, the FDA rejected the drug on both safety and efficacy, requesting more trial data from AstraZeneca before it could proceed any further.
The FDA study found liver toxicity to be six times higher in patients on Exanta compared to those on warfarin, and said the effect was definitely the cause of one death in an Exanta patient and probably the cause of death in one other.
Since then, AstraZeneca has been running trials for the prevention of venous thromboembolism (VTE) up to 35 days after orthopaedic surgery, but a new safety scare has now spelt the end for the drug.
The company says the adverse event showed potential risk of severe liver injury, with a rapid onset of signs and symptoms in the weeks following the end of the 35 days treatment.
AstraZeneca says there is no evidence of risk of liver injury up to 11 days, but use beyond this point is a concern – a restriction which would make Exanta commercially unviable, even if its safety was not an issue.
Exanta is approved in 12 countries (not including either the US or UK) but is currently prescribed to no more than 400 patients in total. These patients will now be switched to other medications and the medicine completely withdrawn.
The company's new chief executive David Brennan thanked doctors, patients and scientists for their commitment to developing Exanta over the years, and pledged that the company would continue to develop other medicines to treat thrombosis.
AstraZeneca is working on AZD0837, a different chemical entity with the same mode of action, which could enter phase III trials within the next few years.
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