Brilinta Approval Shows AstraZeneca's Success With Aspirin Theory, But Can It Change The Market?
Executive Summary
FDA appears to have come around to the "aspirin hypothesis" offered by AstraZeneca PLC to explain poor results for North American patients who took the blood-thinner Brilinta, though labeling takes a somewhat cautious approach that reflects initial concerns about that explanation.
You may also be interested in...
Novo Nordisk's Victoza Adds CV Benefit Claim, But Not For Primary Prevention
US FDA apparently agreed with some of its advisory committee members that liraglutide should be approved for cardiovascular risk reduction only in diabetic patients with established CV disease, not just those with CV risk factors. GLP-1 agonist's labeling is silent on discordant efficacy results in the US patient subgroup in the LEADER trial.
FDA Panel Will Have To Resolve Bleeding Risk With Merck’s Vorapaxar
Novel antiplatelet product has suffered from excess bleeding rates in clinical trials and is searching for an appropriate patient population, after initial hopes of being a blockbuster.
Is Brilinta The Treatment To Keep AstraZeneca’s Lifeblood Flowing?
The company outlined plans to jumpstart growth of the anti-platelet drug Brilinta, including a 100% increase in marketing investment, increased rebates for payers and the addition of 200 nurse educators who will focus on the hospital discharge space.