Posted by George on November 12, 2003 at 15:26:35:
Philadelphia Inquirer
Posted on Wed, Nov. 12, 2003
Firm reports progress of its blood thinner
Research on a pill to prevent strokes was positive, AstraZeneca said. The drug could be sold next year.
By Jed Seltzer and Lisa Richwine
ReutersORLANDO, Fla. - AstraZeneca P.L.C.'s new drug to prevent strokes proved as effective as the standard therapy while offering advantages that could make it the new treatment of choice for millions of people with irregular heartbeats, researchers said yesterday.
AstraZeneca said in a statement that it was on track to seek U.S. and European approval this year for Exanta, the first new anticlotting pill in 60 years, meaning it could reach drugstores next year, with potential sales of $3 billion annually. The drugmaker's U.S. headquarters is outside Wilmington.
The latest large-scale trial of Exanta raised no new major safety issues, encouraging investors who had been concerned that potential liver toxicity might derail the groundbreaking new blood thinner.
The irregular heartbeat called atrial fibrillation, which affects about 2.2 million Americans, causes blood to pool in the heart and clot, making sufferers up to five times more likely to suffer strokes, which can cause paralysis or death.
Results of the latest trial were presented at an annual meeting of the American Heart Association in Orlando.
The incidence of raised liver enzymes, a potential signal of toxicity, was 6 percent for Exanta patients, compared with 0.8 percent for the standard treatment, warfarin.
Nevertheless, the raised enzyme levels with Exanta were "transient" and fell back toward normal within about three months, researchers said.
The incidence of internal bleeding was lower among Exanta patients than those on warfarin, which requires patients to undergo regular blood testing because too much can cause serious bleeding while too little fails to prevent strokes.
"I'm reassured," said Michael Leacock, a pharmaceuticals analyst at ETrade Securities in London. "We'd always expected liver monitoring to be part of the label for Exanta, and I don't think that is likely to change. But, clearly, it is as effective as the very best of current therapy and its prospects are looking good."
With Exanta, patients would take standard doses, rather than the ever-shifting individualized dosing required for warfarin. Moreover, warfarin patients must be monitored monthly for the rest of their lives and have many diet restrictions.
Warfarin, a generic medicine, is also sold by Bristol-Myers Squibb Co. under the brand name Coumadin.