AZ’s antiplatelet recommended for European approval
pharmafile | September 27, 2010 | News story | Sales and Marketing | Brilinta, Brilique, Brillinta, Possia
AstraZeneca’s oral antiplatelet treatment Brilique has received a positive opinion from a key European advisory committee.
A marketing authorisation for the region is expected to follow the CHMP recommendation soon – welcome news for AstraZeneca after the FDA recently said it was delaying its own review of the drug for three months.
The US regulator has not given a reason for moving its decision to December, raising questions about the future of Brilique (ticagrelor) in that country.
The product is an important one for the manufacturer, which faces a number of patent experies, and analysts have suggested the drug, called Brilinta in the US, could make up to $2 billion per annum in peak sales.
It will enter a market in which Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel) currently reigns.
Like Plavix, AstraZeneca’s brand is designed to keep blood platelets from sticking together in order to prevent potentially dangerous blood clots.
If approved by the European Commission, Brilique will be used for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS), an umbrella term for conditions from unstable angina to heart attack.
“Despite advancements in the treatment of ACS, post-ACS death rates remain high,” commented Anders Ekblom, the company’s executive VP of global medicines development.
Data behind the drug includes AstraZeneca’s PLATO trial, which involved 18,000 patients in 43 countries, pitting Brilique against clopidogrel.
PLATO showed that treating 54 patients with Brilique instead of clopidogrel for a year will prevent one cardiovascular death, myocardial infarction or stroke.
The European Medicines Agency’s green light is for Brilique and for Possia, which is AstraZeneca’s alternative name for ticagrelor in Europe.
A spokesman for the manufacturer said commercial sensitivity prevented it from disclosing which brand name would be used in which countries. “We’re not getting into that level of detail,” he said. “But it is exactly the same product.”
Part of the cyclo-pentyl-triazolo-pyrimidines (CPTP) class, Brilique is a direct-acting P2Y12 receptor antagonist and is currently under regulatory review in 12 territories worldwide.
Adam Hill
Related Content
AstraZeneca’s Brilinta combo reduces rate of disabling stroke or death in stroke patients, according to Phase 3 data
AstraZeneca has unveiled new Phase 3 data for Brilinta (ticagrelor) as a treatment for patients …
AstraZeneca presents strong Phase 3 Brilinta data for reducing CV risk
AstraZeneca has unveiled new positive Phase 3 data on the efficacy of Brilinta (ticagrelor) in …
AstraZeneca’s Brilinta proves safety in heart attack patients at Phase 3
AstraZeneca has revealed new Phase 3 data on its direct-acting P2Y12 receptor antagonist Brilinta (ticagrelor) …
