StockMarketWire.com - Pharmaceutical giant AstraZeneca said it drug to treat patients with systemic lupus erythematosus, a serious autoimmune disease, was approved in Japan.

The approval by the Japanese Ministry of Health, Labour and Welfare was based on efficacy and safety data from the Saphnelo clinical development programme, including the Tulip phase 3 trials and the Muse phase 2 trial.

In these trials, more patients treated with 'Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid use compared to placebo, with both groups receiving standard therapy,' the company said.

'The adverse reactions that occurred more frequently in patients who received Saphnelo in clinical trials included upper respiratory tract infection, bronchitis, infusion-related reactions, hypersensitivity reactions and herpes zoster,' it added.

Under the agreement, struck in 2004 with Medarex, which was acquired by Bristol-Myers Squibb in 2009, AstraZeneca will pay the latter a low to mid-teens royalty for sales on Saphnelo dependent on geography.





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