New heart medication, Brilinta (ticagrelor tablets), which makers AstraZeneca had hoped would become a serious rival for Plavix, was not approved by the Food and Drug Administration (FDA) on Friday. Brilinta has not been completely turned down; a CRL (Complete Response Letter) by US regulators requested additional analyses of PLATO (name of Brilinta clinical trial) data. The FDA did not ask for additional studies, though. AstraZeneca says the FDA has not said that additional studies are a prerequisite for eventual approval.

AstraZeneca (AZ) says it is in the process of evaluating the contents of the FDA Complete Response Letter and will respond to the Agency's request for more data as soon as possible. In a communiqué, AZ said it is confident that its NDA (New Drug Application) for tricagrelor will eventually go through, and that it can respond adequately to FDA requests.

Martin Mackay, President, Research & Development, AstraZeneca, said: "Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the BRILINTA NDA review." Brilinta (ticagrelor tablets) Brilinta is a direct-acting P2Y12 receptor antagonist in the CPTPs (cyclopentyltriazolopyrimidines) class of chemicals. It is an oral antiplatelet treatment for ACS (acute coronary syndromes). ACS is a range of conditions caused by lack of oxygen to the heart muscle (myocardium), and involves chest discomfort and other symptoms. According to AstraZeneca, Brilinta is the only reversibly-binding oral ADP receptor antagonist.

The medication was approved by the European Commission on December 6th this year, and trades in Europe under the name Brilique. It is also under regulatory review in 18 countries.

The FDA's latest response has come as a surprise to most market experts, who had expected the drug to be approved without a hitch. AstraZeneca shares dropped 5.5% after the Agency's response became known.

As some of AstraZeneca's blockbusting medications reach the end of their patent life, such as Seroquel and Nexium, the company hopes Brilinta can make up for the expected loss of income.

Annual sales of Brilinta worldwide were expected to reach $2 billion. Now that the US approval will probably be delayed by at least nine months, most likely into the last quarter of 2011, and European launching will mostly occur in the second half of 2011, forecasts are going to have to be drastically cut.

Source: AstraZeneca, FDA



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