By Ben Hirschler
LONDON, March 14 Sat Mar 14, 2015 8:30pm IST
LONDON, March 14 (Reuters) - Long-term use of AstraZeneca's drug Brilinta can cut the risk of death, another heartattack or stroke in patients with a history of past attacks by16 percent, a keenly awaited clinical trial showed on Saturday.
The finding may boost sales of the blood-thinner, whichAstraZeneca is relying on to drive growth, although doctors mustbalance its benefits against bleeding risks.
"There will be more bleeding, but I think the benefit forpatients in terms of reducing their risk of dying or havinganother heart attack or stroke outweighs that," trial researcherMarc Sabatine of Boston's Brigham and Women's Hospital toldReuters.
Importantly, there was no excess of fatal or irreversiblebleeding into the brain.
John Keaney of the University of Massachusetts MedicalSchool, who was not involved in the study, said there was a"fragile balance" to be struck in using potent blood-thinnersthat can trigger bleeding.
He noted that for each 10,000 patients treated, Brilintawould prevent 42 cardiovascular events annually but cause 31major bleeds.
The current standard care for patients more than one year onfrom a heart attack is aspirin alone to prevent clotting, soadding Brilinta would open a major new sales opportunity.
Until now Brilinta has struggled to gain traction, thoughAstraZeneca flagged its potential to sell $3.5 billion annuallyby 2023 when it fought off a takeover bid by Pfizer lastyear.
Analyst forecasts currently suggest sales of $1.5 billion by2020, against $476 million in 2014, according to Thomson ReutersCortellis.
AstraZeneca had said previously the 21,000-patient trial,its biggest ever, was positive but details were only unveiled atthe American College of Cardiology annual meeting, withsimultaneous publication in the New England Journal of Medicine.
Among patients on twice-a-day 60-mg Brilinta plus aspirin,7.77 percent suffered adverse cardiovascular events against 9.04percent for the aspirin-only group, a relative risk reduction of16 percent. For 90-mg Brilinta, the risk reduction was 15percent.
There was major bleeding in 2.30 percent of 60-mg Brilintapatients against 1.06 percent for those taking aspirin only.
AstraZeneca's Brilinta head, Tom Keith-Roach, sees the studyboosting sales and doubling the number of eligible patients. "Ithink it is going to strengthen our trajectory," he said.
Brilinta competes with Sanofi and Bristol-MyersSquibb's older drug Plavix, now available as a cheapgeneric, and Eli Lilly's Effient.
AstraZeneca recently filed for long-term use of Brilinta inEurope and the United States, based on the latest trial results,which showed that the benefit from taking Brilinta continued toaccrue for nearly three years. (Editing by William Hardy)
LONDON, March 14 Sat Mar 14, 2015 8:30pm IST
LONDON, March 14 (Reuters) - Long-term use of AstraZeneca's drug Brilinta can cut the risk of death, another heartattack or stroke in patients with a history of past attacks by16 percent, a keenly awaited clinical trial showed on Saturday.
The finding may boost sales of the blood-thinner, whichAstraZeneca is relying on to drive growth, although doctors mustbalance its benefits against bleeding risks.
"There will be more bleeding, but I think the benefit forpatients in terms of reducing their risk of dying or havinganother heart attack or stroke outweighs that," trial researcherMarc Sabatine of Boston's Brigham and Women's Hospital toldReuters.
Importantly, there was no excess of fatal or irreversiblebleeding into the brain.
John Keaney of the University of Massachusetts MedicalSchool, who was not involved in the study, said there was a"fragile balance" to be struck in using potent blood-thinnersthat can trigger bleeding.
He noted that for each 10,000 patients treated, Brilintawould prevent 42 cardiovascular events annually but cause 31major bleeds.
The current standard care for patients more than one year onfrom a heart attack is aspirin alone to prevent clotting, soadding Brilinta would open a major new sales opportunity.
Until now Brilinta has struggled to gain traction, thoughAstraZeneca flagged its potential to sell $3.5 billion annuallyby 2023 when it fought off a takeover bid by Pfizer lastyear.
Analyst forecasts currently suggest sales of $1.5 billion by2020, against $476 million in 2014, according to Thomson ReutersCortellis.
AstraZeneca had said previously the 21,000-patient trial,its biggest ever, was positive but details were only unveiled atthe American College of Cardiology annual meeting, withsimultaneous publication in the New England Journal of Medicine.
Among patients on twice-a-day 60-mg Brilinta plus aspirin,7.77 percent suffered adverse cardiovascular events against 9.04percent for the aspirin-only group, a relative risk reduction of16 percent. For 90-mg Brilinta, the risk reduction was 15percent.
There was major bleeding in 2.30 percent of 60-mg Brilintapatients against 1.06 percent for those taking aspirin only.
AstraZeneca's Brilinta head, Tom Keith-Roach, sees the studyboosting sales and doubling the number of eligible patients. "Ithink it is going to strengthen our trajectory," he said.
Brilinta competes with Sanofi and Bristol-MyersSquibb's older drug Plavix, now available as a cheapgeneric, and Eli Lilly's Effient.
AstraZeneca recently filed for long-term use of Brilinta inEurope and the United States, based on the latest trial results,which showed that the benefit from taking Brilinta continued toaccrue for nearly three years. (Editing by William Hardy)
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