With two new uses kaput, AstraZeneca touts more long-term Brilinta data at ESC

AstraZeneca has pegged big hopes on its clot-fighter Brilinta, and it continues to roll out numbers designed to underpin those expectations.

The latest? In a new analysis of older trial data, Brilinta showed it could cut the risk of cardiovascular death by 29% compared with placebo. The data came from patients who’d taken Brilinta within two years of a heart attack or within one year of using an anti-clotting med in the ADP class, the best-known of which would be the now-generic Plavix.

That’s an impressive percentage, and AstraZeneca says the analysis of its Pegasus-Timi data supports use of Brilinta longer than the 12-month standard. One of the Pegasus researchers called it “practice-changing.”

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The risk reductions were lower for other measures; Brilinta patients saw a reduction of risk for all-cause death at 20% and an equal reduction in risk on a composite endpoint comprising CV death, heart attack and stroke.

Brilinta is already approved for use up to three years after a heart attack, thanks to the Pegasus results, with backing from England’s cost-effectiveness watchdogs at the National Institute for Health and Care Excellence (NICE). And American College of Cardiology and American Heart Association guidelines rolled out last year put Brilinta in the top spot for certain patients with acute coronary syndrome. To the Pegasus point, the guidelines also recommend using Brilinta for longer than the previous standard of 12 months after a heart attack, also based on AstraZeneca's Pegasus trial.

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Longer-term use means more revenue, of course. Plus, the researchers figure that fewer than half of post-heart attack patients—which number 7 million worldwide—get the follow-up care they need.

It’s no accident that the latest study, up for presentation at the European Society for Cardiology meeting this weekend in Barcelona, draws from the Pegasus trial, the original data from which backed longer-term use of Brilinta for patients who’d had heart attacks or other serious cardiovascular problems. It wasn’t an unqualified win—the absolute risk reduction was too low to support sales goals at the time, the company acknowledged—but it was positive, unlike two other Brilinta trials unveiled more recently.

Last year, Brilinta failed two trials that could have expanded its market considerably. One, the Euclid test for a new indication in peripheral artery disease, fell short. The second, Socrates, failed to deliver proof it could prevent new strokes, heart attack or death in patients who’d suffered a first stroke. Together, those two uses could have accounted for $750 million in additional 2022 revenue, Deutsche Bank analysts calculated.

After both results hit, AstraZeneca's Brilinta chief, Ludovic Helfgott, said the company had downgraded its own expectations for the med, too. “We don't believe the goal of $3.5 billion is attainable,” he said in October. “I think it would be unrealistic to believe that.”

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Can the new analysis of Pegasus turn that around? With guidelines already backing longer-term use of Brilinta, it’s tough to see how. The company has already managed to sew up pay-for-performance deals with payers, too, with Pegasus data as a benchmark for real-world risk-reduction.

AstraZeneca may have a better shot focusing on its emerging market sales. The company recently won reimbursement in China for the med, albeit at a discounted price. And in the first half of this year, Brilinta pulled in almost $500 million in sales, up 28%. Sales in the U.S. grew—as did new scripts, which grew more than a third—but Brilinta got a bigger boost, percentage-wise, in China, where sales grew 42%, executives said during the company's Q2 earnings call. Emerging markets overall saw sales growth of 33%.

Longer term, AstraZeneca could look for another indication in patients with type 2 diabetes and coronary artery disease who hadn’t suffered a heart attack or stroke. That trial, Themis, has data coming in 2019, and AstraZeneca figures regulators will accept applications for expanded use the same year, according to its H2 results announcement (PDF).