AstraZeneca buoyed by Crestor clearance

pharmafile | October 29, 2003 | News story | |   

AstraZeneca's new statin drug has received unanimous approval by a key FDA panel, and now looks set to be launched in the US market this year.

The company have lost billions in revenue because the drug has been held up by the FDA for further scrutiny of questioning its safety profile, but approval from the Endocrinologic and Metabolic Advisory Committee means final clearance should be just weeks away.

Concerns about the drug's safety at high doses led the FDA to demand further data, which AstraZeneca provided by conducting the largest ever pre-approval programme of 12,500 patients, with more than 4000 patients on the 40mg high dose.

Analysts say the approval of the higher dose was key to the drug's success, with doctors still wary of statins after the withdrawal of Bayer's Lipobay/Baycol in 2001 because of sometimes fatal side-effects.

Despite the good news, analysts have maintained their forecast for peak sales of the drug at just over 2 billion, cut back from predictions of $4-5 billion last year.

Related Content

No items found

Latest content