After suffering back-to-back clinical failures last year that forced AstraZeneca to finally back off its projection of a brilliant megablockbuster future for Brilinta, the struggling pharma giant has come up with a positive batch of data that could persuade physicians to extend its use among high-risk heart patients.
Running a sub-analysis of its 2015 PEGASUS-TIMI study, the researchers found a major 29% reduction in the risk of cardiovascular death among high-risk patients who continued to take the clot-fighting drug past the first full year of therapy. The patient population had continued taking aspirin and the drug group was compared with a placebo plus aspirin arm.
The new data also showed a risk reduction of 20% in all causes of death and a 20% in the composite of cardio death, myocardial infarction or stroke. Major bleeding rates were “consistent with the known safety profile of Brilinta,” the company reported.
Any increased use of Brilinta would be cheered at AstraZeneca. Last fall the company had to start edging away from its $3.5 billion projection of peak revenue for the drug, delivering another major blow to CEO Pascal Soriot’s promise to spur annual sales to $45 billion by 2023 — close to twice last year’s total.
Last October Brilinta failed a study for peripheral artery disease, proving no better than aspirin in reducing the risk of death, stroke or heart attack, and that came just 6 months after an earlier flub. There is another major Brilinta trial underway among diabetics, with data expected next year.
Mikael Dellborg, professor of cardiology at the University of Gothenburg and member of the Steering Committee of the PEGASUS-TIMI 54 trial, said:
“The conclusion for both clinicians and patients at high-risk of CV death post-MI is clear: Treatment with Brilinta 60mg, either as continuation therapy after the initial 12 month post-event period, or with as limited interruption as possible, is associated with a clear and favourable benefit-risk ratio for this population of patients. This new insight is potentially practice-changing, as while more than seven million people worldwide suffer a heart attack each year, we know that fewer than half receive adequate long-term treatment to reduce their risk of further CV events.”
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