AstraZeneca scores fast-track FDA review for big new Brilinta use

Analysts weren't as excited about new Brilinta outcomes data as AstraZeneca ($AZN) was. The company is eyeing $3 billion in peak sales for the clot-buster, partly with the help of the PEGASUS trial, unveiled last month. Analysts figure on half that.

But in just a few months, AstraZeneca could have its chance to prove them wrong.

The FDA fast-tracked a proposed new use for Brilinta Wednesday, which means a decision will be due next quarter. Armed with a brand-new indication, AstraZeneca could further fire up its Brilinta marketing push, which already includes a bigger salesforce and more promotional spending. It already includes some results, too; the drug brought in $131 million in the first quarter, up 45% year over year.

The FDA's decision itself is important, though: AstraZeneca wants to market Brilinta to reduce cardiovascular risks in patients for up to three years after a heart attack. Right now, the recommendation is one year, and a longer time frame naturally means higher sales. The FDA could go right along with AstraZeneca's request. Or it could temper those ambitions by labeling the drug in a more limited way.

AstraZeneca says there's a clear need for long-term preventive treatment. "Recent research has shown that one in five patients will have a further heart attack, stroke or cardiovascular death in the subsequent three years following a heart attack, even if they are event-free after the first 12 months," said Elisabeth Björk, AZ's VP in charge of cardiovascular and metabolic drug development, in a statement. "There is a clear need for treatment options beyond the current standard of care of aspirin. … [W]e look forward to working with the FDA as they review our submission."

In any case, AstraZeneca will have to persuade doctors that they should prescribe the drug long-term--and persuade payers to cover that long-term use, too. One potential sticking point is that Brilinta, as a branded med, is more expensive than the previous standard therapy, Plavix, available in sundry generic forms.

Another is safety. In PEGASUS, Brilinta cut the risk of cardiovascular death, stroke and heart attack by 15% to 16%, but the absolute difference was pretty small. About 7.8% of patients in the Brilinta arm suffered one of those complications, compared with 9% of placebo patients. Meanwhile, the rate of major bleeding was about 2.5% in Brilinta patients, compared with 1% of placebo patients.

The New England Journal of Medicine, which published the PEGASUS study, called the risk-benefit analysis "close to an even proposition" in an editorial, saying the prevention numbers were tempered by the bleeding risks.

- read the release from AstraZeneca

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