AstraZeneca’s Brilinta delayed

pharmafile | September 16, 2010 | News story | Sales and Marketing Brillinta, Effient, Plavix, clopidogrel 

AstraZeneca’s blood thinning drug Brilinta faces an extra three month delay to its review by the FDA.

The US regulator has not disclosed the reason for the delay, which raises questions about Brilinta’s (ticagrelor) future and whether its labeling will be limited, reducing its commercial potential.

AstraZeneca is facing a number of impending patent losses and the drug is a key new treatment for it – analysts have previously forecast Brilinta could make up to $2 billion per annum in peak sales.

AstraZeneca said the FDA has added three months to the review, and will now announce its decision on 16 December.

Brilinta is also currently under regulatory review in nine territories around the world, including the European Union, Canada, and Brazil.

If approved, Brilinta would compete against other anti-platelet agents, including Lilly’s Effient, Sanofi’s Plavix (clopidogrel) and forthcoming generic versions of clopidogrel.

Brilinta, like the market’s leading anti-clotting drug Plavix, is designed to keep blood platelets from sticking together in order to prevent the blood clots that can lead to heart attacks and strokes.

In July the FDA’s Cardiovascular and Renal Drugs Advisory Committee supported the drug’s use in patients undergoing percutaneous coronary intervention, as well as its use in patients being medically managed and not expected to undergo surgical treatment.

Brett Wells

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