AstraZeneca PLC (LSE:AZN) announced that Saphnelo has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
SLE is the most common form of lupus, affecting up to 300,000 people in the US, and disproportionately affects the African-American, Hispanic and Asian populations.
It can affect any organ and people often experience debilitating symptoms, long-term organ damage and poor health-related quality of life.
The approval by the Food and Drug Administration was based on efficacy and safety data from two phase III trials and a phase II trial, where patients saw a reduction in organ damage, including skin and joints, and needed fewer oral corticosteroids, which can cause side effects.
Saphnelo caused adverse reactions such as nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough.
It is also being reviewed by the authorities in the EU and Japan, while the FTSE 100 group has started new phase III trials to administer the candidate via injection and to treat other diseases such as lupus nephritis, cutaneous lupus erythematosus and myositis.
AstraZeneca will pay Bristol-Myers Squibb Company (NYSE: BMY) a 13-15% royalty on sales based on the terms of the acquisition for global rights to Saphnelo in 2004.
“Today's approval of anifrolumab represents a big step forward for the entire lupus community,” said Dr. Richard Furie, Chief of the Division of Rheumatology at Northwell Health, New York, and a principal investigator in the Saphnelo clinical development programme
“Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use."