FDA’s Verdict on Brilinta Delayed by Six Months

Delaying the launch in the world’s top market by another few months, U.S. regulators would now decide upon Brilinta’s approval on July, 20.

This decision brought some disappointment for the Anglo-Swedish drug maker, AstraZeneca (AZN.L), as they had already suffered a major blow in December when Brilinta, which was made to compete with Plavix, could not get a clean go by U.S. Food and Drug Administration (FDA).

FDA believes that they need some more time to do a complete analysis before they approve it. At the same time AstraZeneca sounded quite confident about their plea as they are expecting heavy revenue from this drug which is already a success in Europe.

Though Brilinta, which is known as ticagrelor, was able to receive a 7-1 vote in its favor from a U.S. advisory panel but the major hurdle in its way was the lack of its effect in a North American sub-group of patients in a key clinical trial which some experts believe is due to its usage with aspirin.

This drug does not allow dangerous blood clots to happen in patients who had suffered from heart attacks before as it stops blood platelets from sticking to each other and forming a clot that can possibly lead to serious strokes.

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