- The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved AstraZeneca plc’s (NASDAQ:AZN) Saphnelo (anifrolumab) for systemic lupus erythematosus (SLE), a serious autoimmune disease.
- The approval covers adult SLE patients who show insufficient response to currently available treatment.
- The approval was based on efficacy and safety data from the Saphnelo clinical development program.
- 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 (OCS) use compared to placebo, with both groups receiving standard therapy.
- This decision marks the first regulatory approval by the MHLW for a type I interferon (type I IFN) receptor antagonist in Japan.
- AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex Inc in 2004.
- The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb & Co (NYSE:BMS) in 2009. Under the agreement, AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.
- Related content: Benzinga’s Full FDA Calendar.
- Price Action: AZN stock is down 0.19% at $58.62 during the premarket session on the last check Tuesday.
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