Nomura views prospects for AstraZeneca's Brilinta FDA review

Commenting on the upcoming US Food and Drug Administration's review of Anglo-Swedish major AstraZeneca's blood thinner drug candidate, Nomura analyst Amit Roy says that, 'though we are yet to see (critical, yet unpublished) data comparing Brilinta (ticagrelor) with US standard of care Plavix [clopidogrel, from French major Sanofi-Aventis] 600mg, we remain concerned that the FDA's Advisory Panel may not be convinced about Brilinta's benefit over the current US standard of care, Plavix 600mg.

While the PLATO clinical trial pits AstraZeneca's Brilinta primarily against Plavix 300mg, American Heart Association (AHA) 2007 changes to US medical guidelines mean that Plavix 600mg, and not the 300mg dose, is now the US standard of care. Although the PLATO trial included some patients who received Plavix 600mg, AstraZeneca is yet to release data comparing Brilinta with Plavix 600mg. However, Dr Roy believes the FDA's Advisory Panel will show keen interest in this data and may publish this in the briefing documents it is expected to release on July 26.

Sees low likelihood of Brilinta bettering Plavix 600mg