First biologic medicine approved in China for lupus
pharmafile | February 10, 2022 | News story | Business Services |
Nearly half a million people in China have systematic lupus erythematosus (SLE), and more than have of this number will develop lupus nephritis. These individuals are set to benefit from the approval of Benlysta, or generically belimumab, for the treatment of both lupus nephritis and active systemic lupus erythematosus.
Approximately 20% of patients with lupus nephritis progress to end-stage kidney disease in the 10 years following diagnosis.
Benlysta is an intravenous or subcutaneous biologic treatment for both lupus nephritis and active SLE, and is the first and only biologic medicine to be approved in China for these kinds of lupus. Benlysta has been approved for the treatment of adults who are receiving standard of care, and was already approved in China as an add-on therapy in adults and children aged five years and older with active SLE.
GSK Chief Scientific Officer & President of Research & Development Hal Barron said: “Nearly 500,000 people in China have systemic lupus erythematosus and more than half of these patients will develop one of the most common and serious complications, lupus nephritis. Recognising that lupus nephritis can lead to kidney damage, this approval will allow patients in China access to a new treatment option to help slow the progressive nature of systemic lupus.”
The approval is based on data from a Phase III trial which showed the treatment increased renal response rates, and reduced the risk of worsening kidney disease in patients with active lupus nephritis.
SLE is the most common type of lupus, and is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. Lupus nephritis is a frequent complication in people who have SLE. It occurs when lupus autoantibodies affect structures in your kidneys that filter waste, and can lead to kidney failure.
Ana Ovey
