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23 Jul 2017

GSK receives FDA approval for a new self-injectable formulation of Benlysta

The approval marks the first subcutaneous self-injection treatment option for patients with systemic lupus erythematosus.

GSK has announced that the FDA has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus (SLE) is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. The approval marks the first subcutaneous self-injection treatment option for patients with SLE.

After training from their health care provider, patients will be able to administer the medicine as a once weekly injection of 200 mg, from either a single-dose prefilled syringe or from a single-dose autoinjector. This is the second formulation of Benlysta to be granted approval for SLE, adding to the existing intravenous (IV) formulation, approved in 2011, which is administered by healthcare professionals to patients as a weight-based dose of 10 mg/kg, via a one-hour infusion in a hospital or clinic setting every 4 weeks (following an initial loading phase given on days 0, 14 and 28).

Vlad Hogenhuis, Senior Vice President, Head of Specialty Care, GSK said: "We are delighted with the decision. Lupus can affect the lives of patients in many different ways with varied and often unpredictable symptoms. Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta. The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions."

The approval is based on data from the BLISS-SC Phase III pivotal study of more than 800 patients with active SLE, which measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).

Benlysta subcutaneous formulation will be available in specialty pharmacies in the US in late August.

Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017.

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