FDA delays approval of AstraZeneca’s Brilinta
pharmafile | December 20, 2010 | News story | Research and Development, Sales and Marketing | AZ, AstraZeneca, Brilinta, Brilique, acute coronary syndrome
US regulators have delayed approving AstraZeneca’s antiplatelet tablet Brilinta (ticagrelor) because their want more information about a crucial clinical trial.
The company had been hoping for a US decision on its New Drug Application (NDA) this month but the FDA’s complete response letter calls for more work on data from the PLATO trial.
Analysts have predicated $2 billion in peak year sales for the drug, and the hiatus will be particularly unwelcome since the FDA had already delayed its review by 12 weeks before this.
“Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta NDA review,” said Martin Mackay, AstraZeneca’s president of R&D.
Called Brilique in Europe, where it was granted marketing authorisation earlier this month, the drug is the first reversibly-binding oral ADP receptor antagonist.
PLATO forms the basis of the company’s evidence in favour of the drug, and AstraZeneca points out that the FDA is not asking for additional studies as a prerequisite for approval.
PLATO was designed to see whether Brilinta could treat acute coronary syndrome (ACS) patients more safely and effectively than Sanofi-Aventis’ and Bristol-Myers Squibb’s market leader Plavix (clopidogrel).
Both drugs keep blood platelets from sticking together in order to prevent potentially dangerous blood clots.
AstraZeneca says it is “evaluating” the FDA’s request and will respond “as soon as possible”.
“The company remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency’s questions,” it adds in a statement.
PLATO showed that treating 54 ACS patients with the drug instead of Plavix for one year prevented one atherothrombotic event, while treating 91 patients prevented one cardiovascular death with no increase in major bleeding.
Launches in most European countries are anticipated in the second half of 2011. Meanwhile, AstraZeneca is enrolling patients into PEGASUS-TIMI 54, a new study which looks at Brilinta’s efficacy in people who have suffered a heart attack over the past one to three years.
Adam Hill
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