AstraZeneca Responds to FDA Letter - Analyst Blog

AstraZeneca (AZN) recently submitted a response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) for Brilinta (ticagrelor). In its response, the company has provided additional analyses of the Study of Platelet Inhibition and Patient Outcomes (PLATO) as requested by the FDA. AstraZeneca is looking to get Brilinta approved for the treatment of acute coronary syndrome (ACS).

CRL Issued in Dec 2010

The FDA had issued a CRL on Dec 16, 2010 for Brilinta. At that time, the agency had asked AstraZeneca to conduct additional analyses of data from the PLATO trial. The trial was conducted to determine whether Brilinta was more effective in improving cardiovascular outcomes in ACS patients compared to Bristol-Myers Squibb Co./Sanofi-Aventis' (BMY/SNY) Plavix (clopidogrel).

The company said that the additional analyses as requested by the FDA were mainly related to the interactions between Brilinta and high dose aspirin. Importantly, the FDA did not ask the company to conduct additional studies which could have delayed approval further.

Earlier in 2010, Brilinta had received a favorable recommendation from the FDA's Cardiovascular and Renal Drugs Advisory Committee. The FDA advisory panel had recommended the approval of the candidate, based on results from the PLATO trial.

The New Drug Application (NDA) for Brilinta was filed by AstraZeneca in November 2009. The candidate is currently being reviewed in 21 countries. The candidate is approved in the European Union under the trade name Brilique.

Neutral on AstraZeneca

We currently have a Neutral recommendation, which is supported by a Zacks #3 Rank (short-term Hold rating). The approval of Brilinta for ACS would be a major boost for AstraZeneca as several major products are either already facing generic competition or will face generic risk in the 2010 to 2013 time frame.

 
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