FDA’s Verdict on Brilinta Delayed by Six Months
AstraZeneca

AstraZeneca, the makers of Brilinta, had to face another setback when their hopes about the approval of the drug were shattered as FDA postponed its approval by another six months.

US regulators have declared the date of 20 July when they will finally decide whether this new heart drug would receive a green signal or not.

This drug giant firm came out with the statement that they were expecting FDA officials to deliver the verdict with in a period of two months but they seem like postponing it for a much longer time.

Brilinta, which works as a blood thinner, was supposed to be launched to compete Plavix which is manufactured by Sanofi-Aventis and Bristol-Myers Squibb. It was a much awaited decision for AstraZeneca as its rival drug is the world’s second biggest drug by generating the revenue of around $9bn a year.

As this drug has already been launched in UK and doing well so far, it was expected to generate the sales of around $2bn a year on its peak.

Shore Capital keeps its buy recommendation, with analyst Brian White said, “We always felt that this was unlikely given the protracted nature of the FDA review process so far. It is worth noting that our revised forecasts in our recent research note we assumed a 12 month delay from our original expectation of a December launch”.

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