UPDATED: AstraZeneca scores FDA nod for long-term Brilinta use

AstraZeneca's ($AZN) blood thinner Brilinta is officially one step closer to living up to the $3.5 billion ambitions the British pharma laid out last February. The FDA has handed down an approval for long-term use of the drug in patients who have previously suffered heart attacks, a label expansion that will keep sales coming beyond the first year of therapy.

Brilinta tablets at a new, 60 mg dose can now be taken alongside aspirin beyond a year after heart attack to prevent further heart attacks, stroke and cardiovascular death, U.S. regulators said Thursday. The decision follows positive results from the PEGASUS trial, which found that long-term use of the aspirin/Brilinta combo beat out aspirin plus placebo in that department.

The new nod--which puts no limit on how long patients should use Brilinta--will not only help bring in continued sales from patients who are already taking the drug, but it will also loop in newly eligible patients who have had heart attacks more than a year ago.

Most importantly, though, AZ Brilinta team member David Ginivan told FiercePharma in an interview earlier this week, it'll make docs more comfortable with the drug--and more likely to write scripts.

"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."

AstraZeneca is hoping that march will lead Brilinta--which shot up 23% in Q2 to hit $144 million in sales for the period--to the $3.5 billion sales mark by 2023. But as AZ's U.S. president, Paul Hudson, told FiercePharma Friday, it's "too early to make a judgment call" on how quickly the new go-ahead will help get Brilinta there.

Meanwhile, though, the company is testing Brilinta in other areas, including peripheral artery disease and acute ischemic stroke. If it can win additional indications, they'll add up to a "significant financial performance from the brand," Hudson said.

- read the release

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