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www.fdanews.com/articles/67803-french-drug-regulators-reject-astrazeneca-stroke-drug

FRENCH DRUG REGULATORS REJECT ASTRAZENECA STROKE DRUG

January 21, 2005

UK- and Sweden-based drug producer AstraZeneca has suffered a further setback on its Exanta (ximelagatran) treatment, indicated for stroke and thromboembolic complications associated with atrial fibrillation. The company had hoped the drug would become a blockbuster, but French regulators AFSSAPS have now issued a request for further study. Although Exanta was launched in nine European countries and Argentina as a blood clot treatment, the US FDA subsequently rejected the drug.

AstraZeneca's fortunes have been mixed in recent months. Despite recent good news on its Crestor cholesterol drug's approval in Japan, and positive results in US studies of its asthma product line, the company's Iressa lung cancer therapy recently failed in clinical trials. The rejection by French health authorities is widely expected to prompt further concerns on AstraZeneca's product pipeline.