BiotechTracker - Data Support Crestor Approval
May 21, 2003. An abstract further supporting the reassuring risk / benefit profile of AstraZeneca’s (NYSE: AZN) Crestor has been posted on the American Heart Association website and will be presented at the Asia Pacific Scientific Forum in Honolulu in June. The FDA’s endocrinological and metabolic advisory committee meets on July 9 to reconsider Crestor’s utility in the management of hypercholesterolemia and cardiovascular risk modulation. We continue to view Crestor as highly likely to be approved in the U.S. It has already been launched in Canada, the Netherlands, and the U.K. However, Germany, Spain, and Norway continue to balk at approval.  Crestor’s magnitude of therapeutic effect, highest of the statin class, has not been an issue with regulators. Rather, concern has centered on the possibility that its potency could lead to greater adversities, perhaps even on par with those observed with Bayer’s (NYSE: BAY) Baycol prior to its withdrawal from the market. These concerns have largely been theoretical, not data-driven.  No deaths and no cases of rhabdomyolysis, the sometimes fatal adversity attributable to the statin class of drugs, were found attributable to Crestor 10 mg to 40 mg use as of October 2002, at which time data from more than 15,000 patients had been gathered, representing more than 6,500 patient-years of treatment. Additional support for Crestor’s reassuring safety outlook include: percentage of patients in placebo-controlled trials experiencing at least one adverse event 55% in the Crestor groups (n=405) 57% in the placebo groups (n=367) insignificant difference tolerability profile in fixed-dose controlled trials adverse event profile in fixed-dose controlled trials consistent with drug class effects clinically significant alanine aminotransferase (ALT, liver function test) elevations occurred in <0.1% of Crestor recipients transient myopathy occurred in <0.01% of Crestor (up to 80 mg) recipients withdrawal due to adverse event profile consistent with drug class effects.
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