FDA Approves Injectable Drug for Systemic Lupus Erythematosus

Subcutaneous belimumab (Benlysta) is a human monoclonal antibody that treats active, autoantibody-positive systemic lupus erythematosus.

GlaxoSmithKline (GSK) recently announced that the FDA has approved belimumab (Benlysta) in a subcutaneous formulation for the treatment of patients with active, autoantibody-positive systemic lupus erythematosus (SLE), according to a press release.

SLE is an autoimmune disease that causes the body to produce autoantibodies that attack nearly all systems in the body. SLE is the most common form of lupus and there is currently no cure for the disease.

Belimumab is a human monoclonal antibody that binds to BLyS. Since the drug does not bind B cells directly, it inhibits the survival of the cells. Additionally, it lessens the differentiation of B cells into immunoglobulin-producing plasma cells, according to the release.

Belimumab is the first self-injectable drug approved for the treatment of patients with SLE.

After receiving proper training from their healthcare provider, patients will have the ability to self-administer the 200-mg injection once per week. Belimumab will be available as a single-dose prefilled syringe or a single-dose autoinjector, GSK reported.

The new approval is based on positive data from the BLISS-SC phase 3 clinical trial, which included more than 800 patients with SLE, according to the release. The study examined reduced disease activity after 52 weeks of treatment with belimumab plus standard care or placebo plus standard care.

GSK reports that this is the second formulation of belimumab to receive FDA approval to treat patients with SLE. The intravenous formulation was approved in 2011, and is administered by a healthcare professional as a weight-based dose of 10-mg/kg. The infusion formulation must be administered every 4 weeks in a 1-hour session at a hospital or clinic, according to the release.

Subcutaneous belimumab will save patients time and money, as it can be self-injected, according to a press release. The drug will be available at specialty pharmacies in August 2017, GSK wrote.

Additional regulatory submissions for the novel formulation of the drug are currently under review or planned to be submitted this year.

“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 at 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.”