Saphnelo approved in Japan for systemic lupus erythematosus

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AstraZeneca’s Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease, who show insufficient response to currently available treatment.

The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II 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 (OCS) use compared to placebo, with both groups receiving standard therapy.1,2,3

This decision marks the first regulatory approval by the MHLW for a type I interferon (type I IFN) receptor antagonist in Japan. Type I IFN plays a central role in the pathophysiology in lupus and increased type I IFN signalling has been shown to be associated with increased disease activity and severity.

Dr. Yoshiya Tanaka, Professor in the First Department of Internal Medicine at the University of Occupational and Environmental Health, Kitakyushu, Japan and an investigator in the TULIP-2 trial, said: “Compared with other rheumatic diseases, there are limited treatments available for systemic lupus erythematosus and outcomes remain poor for patients in Japan and around the world. Through our own local experience with anifrolumab in clinical trials, we have observed impressive efficacy and improved patient outcomes.”

Dr. Tsutomu Takeuchi, Emeritus Professor of Keio University, Tokyo, Japan and an investigator in the TULIP-2 trial, said: “Our treatment goals in systemic lupus erythematosus are to reduce disease activity, improve quality of life and prevent organ damage from either the disease or the medications used to treat it, especially corticosteroids. Innovative treatments are needed to address these goals. The anifrolumab clinical programme provided compelling evidence that blocking type I interferon is a promising new strategy in the treatment of systemic lupus erythematosus reducing both disease activity across organ systems and corticosteroid use.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Saphnelo is the first and only type I interferon receptor antagonist to receive approval in Japan and represents a major advance in treating systemic lupus erythematosus, a complex heterogenous disease that is challenging to treat and often debilitating for patients. We will now work to bring this medicine to patients in Japan living with this disease as quickly as possible.”

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.1,2,3

SLE can affect any organ, and people often experience inadequate disease control, long-term organ damage and poor health-related quality of life.9,10,11,12 SLE is designated as an Intractable Disease in Japan through a programme that incentivises research and development of drugs to treat rare diseases that lack effective treatments, and also helps reduce cost burden on patients.13 There are approximately 60,000 registered patients with SLE in Japan, and the majority are women diagnosed before age 45.14,15

Results from the TULIP-2 Phase III trial were published in The New England Journal of Medicine, results from the TULIP-1 Phase III trial were published in The Lancet Rheumatology and results from the MUSE Phase II trial were published in Arthritis & Rheumatology. The sub-analysis of patients in Japan enrolled in TULIP-2 was presented at the Japan College of Rheumatology annual meeting in April 2021. Efficacy and safety results from the sub-analysis were consistent with the overall trial populations.16

Saphnelo is approved in the US for the treatment of moderate to severe SLE and is under regulatory review for SLE in the EU. A Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.