FDA Pushes Out Brilinta Action Date - Analyst Blog

AstraZeneca plc (AZN) recently announced that the US Food and Drug Administration (FDA) has extended its review period for Brilinta (ticagrelor) by three months to December 16, 2010. The company is seeking approval for the use of Brilinta in the treatment of acute coronary syndrome (ACS).

Earlier, in July, the FDA's Cardiovascular and Renal Drugs Advisory Committee had recommended the approval of the candidate, based on results from the Study of Platelet Inhibition and Patient Outcomes (PLATO) trial. The PLATO trail was conducted to determine whether Brilinta was more effective in improving cardiovascular outcomes in ACS patients, as against Plavix (clopidogrel) of Bristol-Myers Squibb Co. (BMY).

While the FDA is not required to follow the advisory committee's recommendation, it usually does so.

The New Drug Application (NDA) for Brilinta was filed by AstraZeneca in November 2009. The candidate is currently being reviewed in several territories, including the European Union (EU), Canada and Brazil.

The approval of Brilinta for ACS will be a major boost for AstraZeneca given the fact that the company's major products Toprol XL, Casodex, Plumicort, Nexium, Atacand and Arimidex are either already facing generic competition or will face generic risk in the 2010 to 2013 time frame.

Our Recommendation

We currently have a Zacks #2 Rank (short-term Buy rating) on AstraZeneca, given the June 29, 2010, favorable court ruling on Crestor's US patent, which was upheld and validated until 2016 and proved to be a major win for the company, as well as the FDA Advisory Committee's positive recommendation for the approval of Brilinta.

Longer-term, we have a Neutral recommendation on AstraZeneca.