- AstraZeneca plc on Thursday touted findings from a new analysis that showed its blood thinner Brilinta significantly lowered patients' risk of cardiovascular death — an outcome that is particularly positive given the drug's disappointing history of demonstrating heart health benefits.
- Patients treated with 60 mg of Brilinta twice daily had a 29% drop in their risk of cardiovascular death compared to those receiving placebo, according to the sub-group analysis of data from the PEGASUS-TIMI 54 study.
- The results come just days before the European Society of Cardiology's 2017 Congress. The British drugmaker plans to present more complete results from the Phase 3 study at that meeting.
Brilinta (ticagrelor) hasn't been a star in the clinic since the Food and Drug Administration initially approved it in 2011 as a blood thinning agent for patients acute coronary syndromes. Last March, the drug failed to beat out placebo as a treatment for recurring stroke attacks in the large, global SOCRATES trial. Several months later, it failed again in the EUCLID trial, which tested Brilinta against clopidogrel for the treatment of peripheral artery disease.
The latter setback forced the company to lower its Brilinta sales forecast of $3.5 billion by 2023, with the now-head of AstraZeneca's cardiovascular, renal and metabolic unit, Ludovic Helfgott, telling Reuters that the drug was unlikely to hit that mark.
That's not to say Brilinta isn't profitable. It earned $272 million during the second quarter, a 29% year-over-year increase under constant exchange rates. AstraZeneca expects Brilinta will reach blockbuster status this year, and has maintained the drug's role as a key growth driver that will help the company achieve its long-term (and optimistic) goal of $45 billion in product sales by 2023.
"The latest results highlight a potential protective [cardiovascular] benefit associated with longer-term treatment, versus the standard 12-month post-event treatment period, with Brilinta 60mg," AstraZeneca said in an Aug. 24 statement.
Brilinta prevents atherothrombotic cardiovascular events by antagonizing P2Y12 receptors, which regulate how platelets stick together in the blood. The drug has come to market at the same time as a new wave of oral anticoagulants have taken aim at unseating warfarin — the long-time go-to blood thinner for many physicians and patients.
Such novel oral anticoagulants (NOACs), however, haven't gained as much traction as drug manufacturers and their investors had hoped. Bayer AG and Johnson & Johnson's Xarelto (rivaroxaban), for instance, experienced strong revenue growth throughout 2016 but was also stymied by lawsuits claiming the drug increased patients' bleeding risks. Other NOAC manufacturers have faced similar challenges.
AstraZeneca said major bleeding rates in PEGASUS-TIMI 54 were consistent with Brilinta's previously established safety profile. In addition to the cardiovascular death outcomes, the sub-analysis of the study found treatment with Brilinta correlated with a 20% risk reduction for all causes of death, as well as a composite of cardiovascular death, MI or stroke.
In order to participate in the study, participants must have been taking a daily, low-dose aspirin (75 mg to 150 mg) and have experienced a heart attack, also known as a myocardial infarction (MI), within two years prior to enrollment
AstraZeneca shares were up about 1.4% to $29.54 apiece by market's open on Thursday.