AstraZeneca's Saphnelo For Lupus Treatment Approved In Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved AstraZeneca plc’s 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 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.