With its superstar SGLT2 med Farxiga in the hunt for a game-changing heart failure approval from the FDA, AstraZeneca isn't sleeping on stalwart clot-buster Brilinta's chances. New stroke prevention data could help give the blockbuster a leg up with physicians.
Twice-daily Brilinta on top of aspirin significantly cut the risk of stroke or death over aspirin alone in patients who had suffered a stroke or transient ischemic attack and began treatment within 24 hours, according to top-line phase 3 data released Monday.
In AstraZeneca's 11,000-patient Thales study, patients in the Brilinta arm were treated with a 180-milligram loading dose of the drug on the first day of the study, followed by 90-milligram daily doses from days two through 30, the drugmaker said.
AstraZeneca plans to present full data from the Thales study at an upcoming medical meeting, the company said in a release.
The newest top-line data adds to the longtime blood thinner's growing résumé––and to the heft of AstraZeneca's cardiovascular portfolio. The numbers also represent something of a turnaround after the drug failed to cut the risk of stroke or death in a previous trial in similar patients.
Data from the phase 3 Socrates study released in March 2016 showed 90-milligram doses of Brillinta on top of aspirin failed to top aspirin alone at reducing the risk of stroke in prior stroke patients.
The priority review comes on top of a fast-track designation Farxiga scored in September on the heels of trial data showing it cut CV risks by 26% when added to standard-of-care therapy for heart failure patients with or without Type 2 diabetes as part of its Dapa-HF outcomes trial.
