FDA Staff Mixed On AstraZeneca Blood Thinner
(Washington, DC) -- Staff members of the Food and Drug Administration are giving mixed views on an experimental blood thinner called Brilinta. The main issue for the drug, manufactured by AstraZeneca, is a lack of benefit for patients in North America. A company study shows a significant reduction in deaths and heart attacks for patients in other countries. Some staff members, in memos prepared for an advisory panel that meets on Wednesday, appear willing to accept the differences. However, FDA reviewer Thomas Marciniak cautioned that while AstraZeneca's main study of Brilinta was generally well-run, incomplete follow-up rates are a source of concern. Reviewers in the agency's office of pharmacology recommended Brilinta's approval with a post-market study, "aimed to reconcile the findings" from the U.S. |