HEALTH-ASTRAZENECA-EXANTA (URGENT)
Thu Sep 9, 2004 08:16 AM ET
LONDON, Sept 9 (Reuters) - Officials at the U.S. Food and Drug Administration have questioned both the efficacy and safety of AstraZeneca Plc's (AZN.L: Quote, Profile, Research) new anti-stroke pill Exanta, according to documents posted on the agency's Web site on Thursday.
A briefing note, posted one day ahead of an FDA committee meeting on the drug, said the company may have been "too liberal" in the way it assessed the effectiveness of Exanta against warfarin, the standard treatment. Officials also questioned the drug's possible toxic effects on the liver.
Exanta is the first new anticoagulant pill since the introduction of warfarin, a notoriously difficult drug to use, 60 years ago. Exanta has been associated with raised liver enzymes in some patients but AstraZeneca argues the benefits outweigh the risks.
Thu Sep 9, 2004 08:16 AM ET
LONDON, Sept 9 (Reuters) - Officials at the U.S. Food and Drug Administration have questioned both the efficacy and safety of AstraZeneca Plc's (AZN.L: Quote, Profile, Research) new anti-stroke pill Exanta, according to documents posted on the agency's Web site on Thursday.
A briefing note, posted one day ahead of an FDA committee meeting on the drug, said the company may have been "too liberal" in the way it assessed the effectiveness of Exanta against warfarin, the standard treatment. Officials also questioned the drug's possible toxic effects on the liver.
Exanta is the first new anticoagulant pill since the introduction of warfarin, a notoriously difficult drug to use, 60 years ago. Exanta has been associated with raised liver enzymes in some patients but AstraZeneca argues the benefits outweigh the risks.
