GSK to Request Benlysta Be Approved for Lupus Patients in Japan and China

GSK to Request Benlysta Be Approved for Lupus Patients in Japan and China
lupus clinical trial

GlaxoSmithKline (GSK) reported positive data from a trial of Benlysta (belimumab) for systemic lupus erythematosus in Northeast Asia that will form the basis of a request for the treatment’s regulatory approval in Japan and China.

Study findings (NCT01345253) were presented at the recent 2016 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP) in Washington, D.C.

“Outside of South Korea, where Benlysta has already been granted approval, there is currently no approved biologic treatment option for lupus patients in Northeast Asia, so in the context of the unmet medical need in the region, this study result is extremely important,” David Roth, project leader for Benlysta at GSK, said in a news release.

Benlysta works against the survival of B-cells, including autoimmune B-cells, and reduces the maturation of B-cells into antibody-producing plasma cells. Autoimmune B-cells are involved in the development of autoimmune diseases, such as lupus.

A fourth Phase 3 trial of Benlysta, this study achieved both its main goal and all four secondary endpoints. The randomized trial, conducted in China, Japan and South Korea, ran for 52 weeks, and patients in the Benlysta group received 14 intravenous injections of 10 mg/kg during the first 48 weeks.

Results found that significantly more patients in the Benlysta group reached SLE Responder Index (SRI) compared to those receiving placebo: 54% versus 40%. SRI measures reduction in disease activity defined as clinical improvement, no significant worsening in any organ system, and no worsening in overall patient condition. The various components are measured by individual lupus-specific tools.

Benlysta treatment also lowered the need for steroids among patients, and demonstrated good activity based on a range of other measurements, including SELENA-SLEDAI. Treated patients also had a 50 percent lower risk of severe disease flares.

Adverse effects were similar between the Benlysta and placebo groups — 75% and 76%, respectively. In the group receiving active treatment, 12 percent experienced severe adverse events, and 18 percent of placebo-treated patients. One person in the placebo group died during the trial. All side effects reported during the trial were known from previous studies.

“The data also reinforces our belief that the belimumab mechanism of action is central to disease activity in SLE and we are pleased that the benefit/risk profile remains favorable for patients,” Roth said. “Based on this data and subsequent regulatory submissions, we hope to be able to make Benlysta available to more patients living with lupus in this region.”

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