FDA approves AstraZeneca’s Brilinta after delay
pharmafile | July 21, 2011 | News story | Sales and Marketing | AstraZeneca, Brilinta, Brilique, antiplatelet
The FDA has finally approved AstraZeneca’s oral blood thinner Brilinta after asking for more information on the drug last year.
After twice delaying its decision on Brilinta while it waited for more data from AZ’s main phase III PLATO trial, the US regulator has now approved it for the prevention of heart attack and cardiovascular death in adult patients with acute coronary syndrome (ACS).
Brilinta (ticagrelor) has been shown as a more effective alternative than Sanofi’s standard treatment Plavix (clopidogrel) in reducing the rate of a combined endpoint of CV death or heart attack, but was not better in preventing stroke.
The drug could reach blockbuster status, and recent forecasts predict peak annual sales of around $1.5 to $3 billion.
AstraZeneca’s chief executive David Brennan said: “The FDA approval of Brilinta is good news for patients in the United States and represents a significant milestone as we seek to help ensure ACS patients around the world have access to this innovative medicine.
“With over one million people affected by ACS in the US each year, the fact that physicians have a new and more effective treatment option than clopidogrel to help reduce the rate of heart attack and cardiovascular death in these patients is an important advance.”
AZ said that like other antiplatelet drugs, Brilinta can cause significant, and sometimes fatal, bleeding, but in the PLATO trial the drug did not shown a statistical difference in major bleeding when compared to those taking Plavix.
It did, however, show a much higher risk (25%) of bleeding in a sub-group of patients, leading the FDA to require a risk warning be put on the label.
The drug was approved by the EMA in December last year, where it is known as Brilique, for the prevention of atherothrombotic events in adult patients with ACS.
The drug has now reached its two key markets, but is also under regulatory review in an additional 45 countries, including Russia, India and China.
Ben Adams
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