GSK Applies for Approval of Benlysta, as IV and Injection, as Lupus Treatment in Japan

GlaxoSmithKline (GSK) announced that it has filed a New Drug Application with Japan’s regulatory health agency requesting that belimumab — widely known under the brand name Benlysta — be approved to treat adults with active, autoantibody-positive, systemic lupus erythematosus (SLE, lupus) who do not respond to standard therapy. GSK seeks approval for Benlysta both as an intravenous (IV) infusion and as a subcutaneous injection.

Benlysta is a human antibody that selectively targets the B-lymphocyte stimulator (BLyS), which promotes the survival of immune system B-cells, including those involved in the development of lupus. Benlysta is approved both in Europe and the U.S. as an IV one-hour infusion therapy, to be taken every 28 days, by lupus patients who are under standard care. The subcutaneous injection formulation is currently not approved anywhere, but GSK announced the submission of regulatory applications for its use in the U.S. and Europe in September.

The regulatory application, made to the Japanese Ministry of Health, Labour and Welfare (MHLW), is supported by results from two Phase 3 studies (Northeast Asia and BLISS-SC), pointing toward a beneficial effect of treatment.

The Northeast Asia study (NCT01345253) was carried out in Japan, China, and South Korea, and investigated the efficacy and safety profile of combining monthly IV belimumab (10 mg/kg) and standard of care, compared to placebo and standard of care, for 52 weeks.

The BLISS-SC study (NCT01484496) investigated the effect of weekly subcutaneous injection of belimumab (200 mg, for 52 weeks) plus standard of care, in comparison to placebo and standard of care, in 836 patients with active, autoantibody-positive lupus.

Both studies found belimumab worked to ease disease activity in patients, measured by the Systemic Lupus Erythematosus Responder Index (SRI, a measure of clinical improvement and lack of worsening in patients) at 52 weeks.

“Lupus is a chronic and incurable inflammatory disease, which can affect almost any organ in the body,” said David Roth, project lead for belimumab at GSK, in a press release. “Current treatment options for lupus in Japan are very limited and there is no biologic medicine available that reduces active disease, so this regulatory submission for belimumab is very important progress. If approved, belimumab could address a great unmet medical need for lupus patients in Japan.”