Japanese Regulator Approves GSK’s Benlysta as Add-on Lupus Treatment
Japan’s Ministry of Health, Labor and Welfare has approved Benlysta (belimumab) as an add-on therapy to treat adult patients with systemic lupus erythematosus (SLE) who cannot receive or don’t respond to existing therapies.
The drug, developed by GlaxoSmithKline (GSK), will be available in two formulations, given via intravenous (IV) or subcutaneous (SC) injections. The IV formulation can only be administrated by healthcare practitioners in a hospital or clinical setting, at a dose of 10 mg/kg every four weeks. The SC formulation should be given as a once-weekly single dose of 200 mg of Benlysta.
“Patients living with SLE have limited treatment choices available and may have to endure the associated side effects these can cause,” Vlad Hogenhuis, GSK’s senior vice-president and head of specialty care, said in a Sept. 27 press release. “Benlysta, in its IV form, has been used to treat thousands of patients worldwide and with today’s approval of two formulations, we are delighted that we can now provide an important new treatment option to physicians and SLE patients in Japan.”
Benlysta, an antibody, specifically targets the B-lymphocyte stimulator, or BLyS. By binding BlyS, Benlysta attacks B-cells and reduces inflammatory signals observed in lupus patients.
The Japanese agency based its approval on data from two Phase 3 studies: Northeast Asia IV (NCT01597622) and BLISS-SC (NCT01484496), and by efficacy and safety results from two earlier global BLISS-IV Phase 3 studies: BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384).
In all studies, Benlysta was tested as an add-on therapy, meaning it was given in combination with standard-of-care (corticosteroids, antimalarials or non-steroidal anti-inflammatory drugs). Compared to standard-of-care alone, Benlysta add-on significantly reduced disease activity in lupus patients.
SLE is the most common form of lupus, affecting roughly 70 percent of the estimated five million people with lupus worldwide. Japan alone has about 60,000 registered SLE patients.
Currently, Benlysta IV formulation is approved for the treatment of lupus patients in the United States, Europe, and more than 70 countries worldwide. The U.S. Food and Drug Administration recently approved the drug’s subcutaneous formulation, which is also under regulatory review by the European Commission. GSK plans to seek regulatory approval for Benlysta SC use in other countries throughout the remainder of 2017.