Keywords: USA, FDA, AstraZeneca, Crestor, Regulation

FDA panel reviewer says benefits of AstraZeneca’s Crestor outweigh risks

Article | 14 December 2009

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A US Food and Drug Administration medical reviewer has said the benefit of treating additional patients with Anglo-Swedish drug major AstraZeneca’s cholesterol-lowerer Crestor (rosuvastatin) outweigh the drug’s risks, according to press reports. However, the reviewer said additional study is needed to "further define this benefit-risk ratio."

The company reported that the FDA has posted briefing materials in advance of the December 15 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca..

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In July, AstraZeneca announced that it had filed an sNDA with the FDA which seeks to incorporate outcomes data from the JUPITER study into the Crestor Prescribing Information. As noted in the FDA briefing materials, the sNDA filed by AstraZeneca includes a proposed draft indication based on the JUPITER study as follows:

“For the prevention of cardiovascular disease (CVD) in adult patients with an increased risk of cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, CRESTOR is indicated to:
• reduce the risk of total mortality
• reduce the risk of cardiovascular death
• reduce the risk of stroke
• reduce the risk of myocardial infarction
• reduce the risk of arterial revascularization
• reduce the risk of unstable angina”

Although included in the FDA briefing materials, the Advisory Committee is not expected to vote on the indication proposed by AstraZeneca.

According to the FDA briefing materials, the Committee will vote on whether there is sufficient evidence of a favorable benefit-to-risk profile for rosuvastatin for the primary prevention of CVD in middle and older aged low-to-moderate disease risk individuals with levels of LDL-C <130mg/dl and hscrp ≥ 2mg/l. the emdac will also discuss three non-voting questions related to imbalances in gastrointestinal-related deaths and confusional state as well as the investigator-reported diabetes as observed in jupiter.>

Crestor already a blockbuster

Crestor generated $3.6 billion in 2008 annual sales, up 29% on the previous year, and turnover rose 32% year-on-year in the first nine months of 2009. Statins, including Pfizer’s all-time top-selling product Lipitor (atorvastatin), generated $33.8 billion in 2008 global sales, according to pharmaceutical market research company IMS Health.

Despite strong data from Jupiter and a likely label expansion, we remain cautious on the long-term growth prospects with the introduction of Lipitor generics in late 2011,” wrote Seamus Fernandez, an analyst with Leerink in Boston, in a note to investors quoted by Bloomberg news. “An ideal label expansion from Jupiter may be required to sustain long-term growth,” said Mr Ferdandez.