Regulatory Setback for AstraZeneca - Analyst Blog

AstraZeneca (AZN) recently suffered a major setback with the US Food and Drug Administration (FDA) issuing a complete response letter (CRL) for Brilinta (ticagrelor). The company was seeking approval for the use of Brilinta in the treatment of acute coronary syndrome (ACS).

The agency has asked AstraZeneca to conduct additional analyses of data from the Study of Platelet Inhibition and Patient Outcomes (PLATO). The PLATO 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).

Importantly, AstraZeneca has not been asked to conduct additional studies which could have delayed the approval process even further.

The additional delay in Brilinta's approval is a big disappointment for AstraZeneca which has been banking on Brilinta's approval to help make up for the loss of revenues that will take place with the genericization of key products. The FDA was previously expected to deliver its decision regarding the candidate's approval status in mid-Sept. However, at that time, the agency extended its review period by three months.

We note that earlier this year, 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 eighteen territories. The candidate received approval in the European Union earlier this month under the trade name Brilique.

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. The company is currently reviewing the CRL and intends to respond to the agency soon.

 
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