Reuters Health Information (2003-09-02): Risk data on Astra's Exanta deemed reassuring
Drug & Device Development
Risk data on Astra's Exanta deemed reassuring
Last Updated: 2003-09-02 16:26:07 -0400 (Reuters Health)
VIENNA (Reuters) - New safety data on AstraZeneca Plc's anticoagulant drug Exanta (ximelagatran), unveiled on Tuesday, are reassuring, despite hepatotoxicity seen in some patient, according to one of the experts leading clinical trials of the agent.
Professor Bertil Olsson of University Hospital, Lund, Sweden, gave the first detailed figures on the drug's safety profile to the annual meeting of the European Society of Cardiology. The latest data were compiled in late August.
A total of 107, or 6.3%, of Exanta patients in the so-called Sportif III trial had liver enzyme levels three times above normal and 48 had treatment discontinued because their enzyme levels were five times above normal, he said.
An additional seven patients, or 0.4%, had levels of bilirubin that were two times above normal.
One industry analyst said the number of bilirubin cases was somewhat higher than expected, though still a low number.
Overall, Dr. Olsson said he was satisfied with the relative risks and benefits of Exanta, which is being assessed as an alternative to warfarin in preventing stroke.
"With the information we have to date from the Sportif III trial, (elevated liver enzymes) doesn't seem to be a problem," Olsson told Reuters, adding no patients had shown clinical symptoms.
"It is there. We should observe it and we should stick to the rules we have had in the study, which is that once it exceeds five times the limit of normal, we stop the treatment."
"This will affect slightly less than three percent of the patients," he added.
Both Exanta and warfarin increase the risk of bleeding in patients, although the 4.6% who experienced serious bleeding events with Exanta was significantly lower than the 6.1% seen with warfarin.
Clinicians attending the medical meeting in Vienna gave a generally favourable reception to Exanta, which AstraZeneca plans to file for approval with regulators later this year.
A number, however, said price could be a barrier to its use in Europe, where generic warfarin costs just a few cents per patient a day. AstraZeneca has yet to set a price for its new drug but analysts expect it to cost more than $1 a day.