The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Saphnelo (anifrolumab) to treat adult patients with systemic lupus erythematosus (SLE).
SLE is a serious autoimmune disease that can affect any organ and people often experience inadequate disease control, long-term organ damage and poor health quality of life.
According to the company, there are around 60,000 registered patients with this disease in Japan.
The MHLW approval is based on the data obtained from clinical trials conducted on the drug to evaluate its efficacy and safety.
The clinical trials include the Tulip Phase III trials and the Muse Phase II trial, which showed overall disease activity reduction in the patients’ organ systems including skin and joints as well as reduction in oral corticosteroid (OCS) use compared to placebo.
The trials were conducted in patients with moderate to severe SLE who were receiving standard therapy.
This decision is the first regulatory approval by the Japanese agency for a type I interferon (type I IFN) receptor antagonist.
Keio University, Tokyo, Japan emeritus professor and TULIP-II trial investigator Tsutomu Takeuchi 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.”
Furthermore, the adverse reactions occurred in patients who received Saphnelo during the clinical trials include infusion-related reactions, bronchitis, herpes zoster, hypersensitivity reactions and upper respiratory tract infection.