AstraZeneca's Brilinta falls short in phase IV study
- AstraZeneca's Brilinta is used for the reduction of thrombotic cardiovascular (CVD) events in patients with acute coronary syndromes (ACS).
- Phase IV data show no benefit to administering Brilinta before percutaneous coronary intervention (PCI). However, doing so does not increase the risk of bleeding. On the positive side, pre-procedural use of Brilinta decreases the risk of post-PCI stent thrombosis.
- Brilinta has stumbled its way through the approval process and underperformed in post-approval sales.
When AstraZeneca was first seeking approval for Brilinta, the FDA delayed its initial review twice in 2010. Then the European Medicines Agency requested more data in 2013 during its own review process for the drug.
Analysts anticipate Brilinta sales of just $500 million this year, in contrast to initial rosy projections of $2.5 billion when the drug was first approved. Although the stent thrombosis results from the latest stage IV trial do not correlate with an increased survival advantage, they could present an opportunity for AZ to capture more market share and broaden use of Brilinta. In addition, AZ is conducting trials comparing Brilinta and aspirin compared with aspirin alone for use in heart attack patients as a form of secondary prevention.
- pharmafile.com Mixed results for AZ’s troubled Brilinta