FDA recommends Brilinta
pharmafile | July 30, 2010 | News story | Sales and Marketing | 2010 financials, AstraZeneca, Brillinta, Q2
FDA advisors have voted in favour of AstraZeneca’s antiplatelet drug Brilinta, which is currently seeking a licence for the reduction of thrombotic events in patients with acute coronary syndromes.
The US regulator’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.
AstraZeneca’s chief medical officer Howard Hutchinson said: “We are pleased with the Advisory Committee’s recommendation to support the approval of Brilinta [ticagrelor]. We look forward to continued discussions with the FDA as it evaluates the panel’s recommendation and completes its review of the NDA.”
Brilinta is also currently under regulatory review in nine territories around the world, including the European Union, Canada, and Brazil.
If approved Brilinta will be competing against other anti-platelet agents including Lilly’s Effient and Sanofi’s Plavix (clopidogrel), as well as upcoming generic versions of clopidogrel.
Industry analysts EvaluatePharma currently have Brilinta in their top 20 most valuable R&D projects, with the drug forecast to make just under $2 billion per annum by 2016.
Emerging markets lift AstraZeneca’s Q2
Meanwhile strong performance in emerging markets helped edge AstraZeneca into low single-digit growth in the second quarter, despite generic pressures and stricter pricing measures in Europe.
Revenue for the second quarter rose just 1%, based on constant exchange rates, to $8.2 billion and the company’s core profit was up 4% to $3.5 billion on the same basis.
Generic competition was particularly felt in the US, where revenue declined by 4% following sales erosion for AstraZeneca’s blood pressure treatment Toprol-XL, Pulmicort Respules for children’s asthma and Casodex, a hormonal therapy for prostate cancer.
In the rest of the world revenue was up 5%, largely as a result of a 16% increase in emerging markets, which accounted for approximately three-quarters of the revenue growth outside the US.
But revenue in Western Europe rose by just 1% due to government pricing restrictions in Germany, Spain and Italy.
Chief executive David Brennan said: “Our second quarter performance reflects continued strong growth in our emerging markets and good performance for key brands Crestor, Seroquel and Symbicort.
Ben Adams
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