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(Alliance News) - AstraZeneca PLC on Tuesday said its Saphnelo treatment has been approved in Japan for adults with serious autoimmune disease.
The FTSE 100 constituent said the Japanese Ministry of Health, Labour & Welfare has authorised the use of its anifrolumab drug, which has the brand name Saphnelo.
The drug is designated for use in adults with systemic lupus erythematosus who show insufficient response to currently available treatment, the company said.
Systemic lupus erythematosus is a serious autoimmune disease that can affect any organ often causing long term organ damage and reduced quality of life. There are around 60,000 registered patients with this form of lupus in Japan.
The approval is based on efficacy and safety data from clinical trials of the drug, including the Tulip Phase 3 trials and the Muse Phase 2 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 use compared to placebo, with both groups receiving standard therapy," AstraZeneca noted.
However, the company added that: "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."
This is the first regulatory approval by the Japanese agency for a type I interferon receptor antagonist.
"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," said Tsutomu Takeuchi, Professor at Keio University in Tokyo and an investigator in the Tulip-2 trial.
In August, Astra's Saphnelo treatment was approved in the US for patients with moderate to severe systemic lupus erythematosus.
Saphnelo is currently under regulatory review in the EU.
The pharmaceutical company said it has begun a Phase 3 trial of using subcutaneous delivery to treat systemic lupus erythematosus patients with Saphnelo. Further Phase 3 trials are planned to test the drug's effectiveness in rare and autoimmune conditions: lupus nephritis, cutaneous lupus erythematosus and myositis.
Shares in AstraZeneca were trading down 0.7% at 8,509.48 pence each in London on Tuesday morning.
By Scarlett Butler; scarlettbutler@alliancenews.com
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