Drug Name: Brilinta (ticagrelor)
Developer: AstraZeneca (AZN)
Indication: Acute Coronary Syndromes (ACS)
Probability of Approval: 91%(B)
Developmental Stage: U.S. and E.U. Regulatory Review
Next Catalyst: Cardiovascular and Renal Drugs Advisory Committee NDA Review, tomorrow
For background, see inThought Research: Brilinta’s Strong Momentum Into FDA Panel, July 19, 2010; Brilinta Looking Better than Effient, March 29, 2010; Brilinta Set to Take On Plavix and Effient, January 25, 2010; The Problems with Prasugrel, Part II, January 20, 2010; Three Cardiology Drugs Gain Attention, September 10, 2009; and Introduction to Novel Antithrombotics for ACS, July 13, 2009.
inthought research
July 27, 2010
Leon Henderson, MD
• No major surprises are contained in the FDA briefing documents for tomorrow’s Cardiovascular and Renal Drugs Advisory Committee meeting to consider U.S. approval of AstraZeneca’s (AZN) Brilinta (ticagrelor), a potential competitor to Plavix (clopidogrel) and Effient (prasugrel).
• The documents reinforce Brilinta’s benefit-risk profile outlined in six inThought Research Reports published since July 2009. Brilinta’s inThought Approvability Index score remains 91%(B) for acute coronary syndromes (ACS).
• The greatest threat to an immediate approval recommendation is Brilinta’s inferior performance in North American cohorts. Although the degree to which usage of higher dose aspirin in such populations contributes to muted Brilinta advantage will be debated at the panel meeting, FDA reviewers appear to favor additional study after approval, not before.
• inThought expects the FDA panel to reward Brilinta’s international evidence of therapeutic benefit in both interventionally and medically managed (STand non-ST elevation) myocardial infarction and unstable angina scenarios.
