AstraZeneca's Brilinta won its coveted stroke-prevention nod. Will it be enough to boost long-term sales?

AstraZeneca
The FDA has approved AstraZeneca's Brilinta, used on top of aspirin, to reduce the risk of additional stroke in patients who already had a stroke. (AstraZeneca)

A few months ago, AstraZeneca’s Brilinta added a new U.S. indication to reduce the chance of a first heart attack or stroke in certain high-risk patients. Now, the blood thinner has won a green light to prevent another stroke in patients who already suffered a mild-to-moderate one.

Specifically, the FDA approved Brilinta alongside aspirin to reduce the risk of another stroke in two groups of stroke patients: those with acute ischemic stroke who score at or below 5 on the National Institutes of Health Stroke Scale and those with a high-risk transient ischemic attack, also known as mini-stroke, AstraZeneca said Friday.

The new nod adds to Brilinta’s original 2011 approval to prevent secondary cardiovascular events in high-risk patients who have already experienced a heart attack.

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

“One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days,” said Clay Johnston, lead investigator of the phase 3 Thales trial, which supported Brilinta’s current approval.

In the Thales study, adding Brilinta 90 mg twice daily to daily aspirin cut the rate of stroke or death by 17% within 30 days. The improvement was mainly driven by a reduction in stroke. Altogether, 5% of 276 patients on the Brilinta-aspirin combo had another stroke, versus 6.3% among 345 patients in the solo aspirin group, according to data published in The New England Journal of Medicine.

RELATED: AstraZeneca has dumped billions into Brilinta R&D, but will it ever pay off?

At that dosage, patients on Brilinta did experience a higher rate of bleeding, at 0.5%, compared with 0.1% for solo aspirin.

The secondary stroke prevention label came five months after Brilinta, given 60 mg twice daily, was cleared for use alongside aspirin to prevent a first heart attack or stroke in at-risk patients with coronary artery disease.

Despite all the effort and R&D investment plowed into expanding Brilinta’s use, the drug may never turn a profit for AZ as generics are slated to hit in 2024 in the Western world, EvaluatePharma previously projected. Brilinta generics are already on sale in China.

For now, though, Brilinta is one of the growth drivers at AZ, only to a much lesser extent than the British pharma’s oncology business. In the first nine months of 2020, the drug sold $1.23 billion, up 7%. However, its performance in the third quarter could spell trouble.

RELATED: Eli Lilly, Pfizer, Merck among Big Pharma losers in China's latest round of procurement bidding

Sales of Brilinta slid 7% to $385 million in Q3 due to COVID-19 and a wholesaler inventory adjustment in China after the drug was found to be squaring off against local generics for a place in the country’s bulk procurement scheme. In late August, AZ decided not to compete in the latest price-cutting round for allocated hospital procurement there and handed the tender to generics players, but it still faced a mandatory price cut of 30% because of the bulk procurement rule.

Bracing for that impact, AZ is now channeling patients to retail pharmacies in China to retain loyal users and expanding to more outlets, hospitals and clinics to slow down the erosion, Leon Wang, AZ’s head of international markets, told investors on a call Thursday.

Applications for the secondary stroke use are also under review in China and the EU.