AstraZeneca Confident Oral Antiplatelet Drug Brilinta Will Be Approved By FDA

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Main Category: Heart Disease
Also Included In: Blood / Hematology;  Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 22 Jan 2011 - 10:00 PDT


AstraZeneca says it has responded to the FDA's queries regarding Brilinta, its oral antiplatelet treatment for acute coronary syndromes, and believes its marketing application in the USA will be approved. The FDA (Food and Drug Administration) had requested further data on Brilinta's interaction with high-dose aspirin.

The drugmaker had expected the FDA to approve Brilinta (ticagrelor) in December 2010 and had hoped it would become a serious rival for the world's second-biggest selling medication, Plavix with annual sales exceeding $9 billion globally, sold by Sanofi-Aventis and Bristol-Myer's Squibb. However, the US Agency responded to the drug application with a request for more data - a Complete Response Letter (CRL) requesting additional analyses of the trial data (not additional studies).

Ticagrelor has been approved in Europe, and AstraZeneca needs a new blockbuster to make up for lost revenues as patents expire on some of its best-selling drugs, such as Seroquel (for schizophrenia) and Nexium (for heartburn).

Although an FDA Advisory Panel voted 7 to 1 in favor of approving Brilinta in July 2010, a sub-group of patients in a North-American trial failed to show a clear benefit, resulting in a setback for a smooth transition to approval in the USA.

Experts wondered whether the North American trial's lack of clear benefit was due to an interaction between ticagrelor and aspirin. Most US patients on Plavix, for example, are also on higher aspirin doses than their European counterparts.

In a communiqué, AstraZeneca wrote:

"The additional analyses of the PLATO trial requested in the CRL focused primarily on interactions between ticagrelor and high dose aspirin. AstraZeneca believes these supplementary analyses support the hypothesis that the apparent difference in treatment effect observed in the US and non-US patient subsets in PLATO is most likely a reflection of an underlying interaction between ticagrelor and higher doses of aspirin."

The company added that it continues to believe that the explanations for the efficacy difference between trials are due to either the play of chance or an interaction between high dose aspirin and tricagrelor.

The FDA will now look through AstraZeneca's response to decide whether the submitted data are complete and whether to designate the review as a Class 1 (2 month) or Class 2 (6 month) review cycle.

AstraZeneca's communiqué, on a positive note, wrote:

"AstraZeneca remains confident in the NDA submission for ticagrelor and will continue to work with the FDA to progress towards the completion of the review of the NDA for ticagrelor."

The London stock market responded positively to this news, with a 1.3% rise in AstraZeneca share prices, higher than the otherwise quiet European drugs sector.

Ticagrelor prevents dangerous blood clots in patients with previous heart attacks or serious chest pains. It is known as Brilique in Europe and Brilinta in the USA.

Sources: AstraZeneca, FDA

Written by Christian Nordqvist


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