Japan approval for Darzalex and Benlysta

In a flurry of new drug approvals, Japan’s Ministry of Health Labor and Welfare (MHLW) has cleared for marketing a new drug for lupus as well as one for multiple myeloma, both from European drugmakers.

UK pharma major GlaxoSmithKline (LSE: GSK) announced today that the MHLW) has approved Benlysta (belimumab) for the treatment of adult patients with systemic lupus erythematosus (SLE) who are inadequate responders to existing therapies. Benlysta is for use as an add-on therapy in autoantibody positive SLE patients. SLE is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time, affecting almost any system in the body.

The medicine will be available for patients in two formulations, as an injection, for intravenous (IV) use and an injection, for subcutaneous (SC) use. The IV formulation is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinical setting every four weeks (following an initial loading phase given at Weeks 0, 2 and 4). The subcutaneous formulation can be administered as a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector.