New Self-Injectable Form of Lupus Drug Approved by the FDA

Patients with systemic lupus erythematosus (SLE) will now have the option to self-inject their medication thanks to the FDA approval of GSK’s reformulated lupus drug, Benlysta (belimumab). SLE is the most common form of the chronic disease and the new Benlysta could help patients better manage the condition in their own homes, as opposed to having to visit hospitals regularly for treatment.

As an autoimmune disease, patients with SLE produce autoantibodies which recognize and attack the body’s own tissues and organs. Approximately 70 percent of those with lupus are diagnosed with the SLE subtype, totaling 170,000 to 200,000 individuals in the US alone.

Benlysta was originally approved by the FDA in 2011, making it the first new lupus therapy to be made available to patients in over 50 years. This monthly treatment would be administered intravenously by healthcare professionals, taking about an hour for one session.

In comparison, self-injectable Benlysta is administered subcutaneously on a weekly basis. Much like diabetic patients who rely on insulin, patients with lupus will receive training from their healthcare provider in order to learn how to properly use Benlysta pre-filled syringes or auto-injectors.

“We are delighted with today’s decision. Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms,” said Vlad Hogenhuis, Senior Vice President, Head of Specialty Care, GSK. “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.”

Benlysta is a human monoclonal antibody which inhibits a protein known as BLyS. Since BLyS is involved in survival of autoreactive B cells which are responsible for some of the damaging effects of lupus, the drug helps to eliminate the autoreactive immune cells.

According to GSK, the new self-injectable Benlysta will be available in US specialty pharmacies late next month. The pharmaceutical company also disclosed that the reformulated lupus drug is currently under review for approval in other countries.