LONDON--Before September is out, AstraZeneca ($AZN) predicts it'll have a label expansion in hand for growth prospect Brilinta, based on results of its PEGASUS study. And when Brilinta gets that go-ahead, its sales force will be raring to go.
After talking up the pivotal PLATO study for the last 5 years, the company's U.S. sales ranks--made up of about 550 reps, as well as an additional 150 or so cardiovascular nurse consultants--is champing at the bit to have new data and a new indication to talk about, David Ginivan, part of AZ's Brilinta team, told FiercePharma in an interview.
The thing is, AZ doesn't yet know what the expanded label will say. PEGASUS found that long-term use of the drug plus aspirin helped prevent heart attacks, strokes, and cardiovascular death in post-heart-attack patients--and did so better than long-term aspirin plus placebo. The British drugmaker wants to market Brilinta to reduce CV risks in patients for up to three years after heart attacks, but the new nod could come with limitations.
The company should have those specifics in "days, rather than weeks," according to Ginivan. But the way he sees it, it's the approval itself--not its breadth--that's most important for building toward AZ's $3.5 billion long-term sales goal for Brilinta, outlined last February.
"Are we going to see a massive uptick in sales? Probably not, but it's going to be that steady march and growth," he said. "This is going to add to the confidence that physicians currently have--it's going to add to the confidence of being able to prescribe that drug."
And an FDA thumbs-up for Brilinta treatment beyond the one-year mark could actually foster more use in the drug's current eligible patient pool, Marc Ditmarsch, AstraZeneca's global lead for Brilinta, told FiercePharmaMarketing.
"There could be a substantial halo effect," he said. In the U.S., there's a tendency to discontinue therapy with P2Y12 antiplatelet drugs such as Brilinta early on after patients first develop acute coronary syndrome, but "with this data at hand, I think there's a much bigger drive for physicians to make sure that patients stay on therapy for the first year," he said.
Meanwhile, AstraZeneca is working on grabbing other indications, too, and it'll have plenty of data coming along next year to help build its case. Its SOCRATES trial, looking to read out in Q1 of next year, is looking at Brilinta in ischemic stroke, and later on, in Q4, the drugmaker has a peripheral arterial disease study reading out, Ginivan said.
- see the AZ release
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