Benzinga | Sep 28, 2021 08:13AM EDT

AstraZeneca's Saphnelo For Lupus Treatment Approved In Japan

* 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.