FDA staffers pretty positive on AstraZeneca's Brilinta

Documents released ahead of a US regulatory panel meeting on Wednesday suggest that AstraZeneca’s investigational oral antiplatelet therapy Brilinta has a good chance of getting a recommendation for approval.

Papers have been published on the website of the US Food and Drug Administration ahead of a meeting of its Cardiovascular and Renal Drugs Advisory Committee on July 28 which will evaluate Brilinta (ticagrelor). The company is hoping the treatment will get the green light for the reduction of major adverse cardiac events in patients with acute coronary syndrome.

According to FDA staffers, Brilinta appears effective, based on data from the 18,624-patient PLATO study, the Phase III head-to-head trial comparing the drug plus aspirin with Sanofi-Aventis/Bristol-Myers Squibb’s big-selling bloodthinner Plavix (clopidogrel), also with aspirin. However they highlighted the difference in effectiveness between US and non-US participants in the trial.

AstraZeneca believes that higher aspirin doses in the USA may explain the difference but some reviewers are not convinced. Nevertheless, the staffers at the FDA’s Office of Clinical Pharmacology said that they recommend approval of Brilinta, so long as a post-marketing study focusing on the disparity in the USA is carried out.

Brilinta is the first in a new class of drugs, the CPTPs (cyclo-pentyl-triazolo-pyrimidines) and is chemically distinct from the thienopyridines, such as Plavix and Eli Lilly/Daiichi Sankyo’s Effient (prasugrel). The treatment, which is the first reversibly-binding oral P2Y12 adenosine diphosphate receptor antagonist. was filed with regulators in Europe last October and analysts believe Brilinta could be a blockbuster.