AstraZeneca heart disease drug gets wider FDA approval


AstraZeneca received a much-needed boost when its blood-thinning drug, Brilinta, a potential blockbuster, was approved by the US health regulator for wider use.

The Food and Drug Administration approved Brilinta tablets for longer-term use in patients with a history of heart attack. The new 60mg dose can be taken twice a day along with aspirin beyond a year after a heart attack. Until now, the blood thinner could only be prescribed for one year after a heart attack, as a 90mg dose.

Brilinta is one of the big earners AstraZeneca is counting on to offset falling sales from older bestsellers as they come off patent, such as Nexium and Crestor. Brilinta has had a bumpy ride since being launched in 2011 but the AstraZeneca boss, Pascal Soriot, has talked it up as a diamond in the rough.

The British drugmaker is also preparing to present data on its lung cancer medicines, another key part of its portfolio, at a conference in Denver, Colorado, which begins this weekend. AZD9291, one of its most promising new drugs, will be the focus of six presentations. It targets a genetic mutation that helps tumours evade current lung cancer pills.

Antoine Yver, head of oncology in global medicines development at AstraZeneca, said: “AZD9291 is moving through clinical development with unprecedented speed, and was recently granted US priority review designation.”

The FDA move comes just days after the European Society of Cardiology endorsed the longer-term use of Brilinta and other blood clot preventers. A decision from European regulators is expected in the first six months of next year.

Marc Sabatine, the lead investigator in Boston for a large clinical study involving more than 21,000 patients, said it showed that the use of Brilinta together with aspirin in patients who had suffered a heart attack significantly reduced the risk of dying from cardiovascular causes, having another attack or a stroke in the long term.

The FDA decision will boost sales of the heart drug, which is used to prevent blood clots that can cause heart attacks, strokes and deaths. AstraZeneca has estimated that annual sales could reach $3.5bn (£2.29bn) by 2023 and a spokeswoman said the expanded label for Brilinta reinforces the company’s confidence in that forecast. Brilinta sales rose 23% to $144m in the second quarter, and totalled $476m last year.

There is now no time limit on how long Brilinta can be taken, which means patients could stay on it indefinitely. But doctors will have to weigh Brilinta’s benefits against risks of bleeding.

Deutsche Bank analysts Richard Parkes and Sarah Potter said: “In theory, extended use of Brilinta could double the addressable patient population for the drug. In reality, we believe the increased bleeding risks and modest net benefit is likely to limit extended duration therapy to selected patients with low risk of bleeding complications and particularly high cardiovascular risk.

They added: “Given that 20% of current generic Plavix use is believed to be in patients on extended therapy, this still represents a significant growth opportunity.”

Rival blood thinner Plavix, made by Bristol-Myers Squibb, has come off patent and so cheaper generic versions of it are available.

The new Brilinta 60mg tablet is expected to be in US pharmacies by the end of this month.

Powered by article was written by Julia Kollewe, for on Friday 4th September 2015 15.05 Europe/ © Guardian News and Media Limited 2010


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