JAPANESE APPROVAL FOR ASTRAZENECA CHOLESTEROL TREATMENT

Japan's Pharmaceutical and Medical Safety Bureau has approved UK- and Sweden-based drugmaker AstraZeneca's Crestor drug. The decision follows an approval recommendation by the country's Pharmaceutical Affairs Council last month. Crestor, a statin indicated for high cholesterol, is to be available in 2.5-, 5- and 10-mg doses, and will be marketed in Japan by local partner Shionogi.

However, AstraZeneca will be required to conduct a monitoring programme for the drug after its commercial launch, in order to address concerns on the drug's possible side effects. Although approved in the US and Europe, the treatment has attracted allegations in the US that high doses could be linked to increased risk of muscular degenerative disorder rhabdomyolysis. Further, the company continues to await confirmation of the drug's pricing and reimbursement details.