JAPANESE APPROVAL RECOMMENDATION FOR ASTRAZENECA'S CRESTOR

The Japanese Pharmaceutical Affairs Council has recommended UK-based drug major AstraZeneca's Crestor for approval. The drug, a statin indicated for high cholesterol, is to be marketed in Japan with local pharmaceuticals producer Shionogi, pending agreement on pricing and reimbursement. The medicine is to be issued with a starting dose of 2.5mg, compared to the minimum dose of 5mg in the US.

The news is a positive development for AstraZeneca, which has suffered after the recent failure of its lung cancer treatment Iressa in clinical trials. Nevertheless, the company has agreed to set up a surveillance programme to assess the drug's risk-benefit profile in Japan prior to its commercial launch. Meanwhile, recent comments from the US FDA have sounded a note of caution on high intakes of the drug, which US consumer groups have alleged to carry a risk of the muscular degenerative disorder rhabdomyolysis.