Crestor approval recommendation in Japan provides respite for AstraZeneca

Anglo-Swedish drug major AstraZeneca has finally received some good news to end a difficult 2004, with the Japanese Pharmaceutical Affairs Council recommending approval of the company's cholesterol-lowering drug Crestor (rosuvastatin), about which safety questions have recently been raised in the USA during the Senate hearing into Merck & Co's withdrawal of its arthritis drug Vioxx (rofecoxib; Marketletters passim and page 8 this issue).

AstraZeneca's share price had dropped around 30% since September, falling heavily last month on the revelation that the firm's lung cancer drug Iressa (gefitinib) had failed to meet the primary endpoints of a clinical study. However, the Japanese news gave the stock a small fillip. Although the London Stock Exchange was closed when the Japanese news came through, the shares rose 1.5% in US trading.

The Council's recommendation is contingent on final agreement of a post-marketing surveillance program. The recommended starting dose of 2.5mg is in line with normal clinical practice in Japan where, compared to the western world, lower-dose ranges of drugs, including statins, are made available, the company notes.