|
|
Jim Byard's Health Beat |
|
7/27/2010
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 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 post-market study, "aimed to reconcile the findings" from the US.
|
«
Return to previous page
»
Send to a friend
|
|
|
On Air Now
 |
|
5:30AM - 10AM
|
Weather
|