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Pharmaceutical industry

FDA Approves BENLYSTA for Treatment of Systemic Lupus Erythematosus

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has approved BENLYSTA, a medication developed by Human Genome Sciences, Inc. (HGS) and GlaxoSmithKline PLC (GSK), for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. This marks the first new treatment for SLE in over 50 years.

BENLYSTA, also known as belimumab, is a monoclonal antibody that targets the protein BLyS, which is involved in the production of autoantibodies that contribute to the disease. The medication has been shown to reduce the activity of autoantibodies and improve symptoms in patients with SLE.

"We are honored to have the opportunity to bring BENLYSTA forward in the United States as the first new drug for systemic lupus in more than 50 years," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We expect to have this novel therapy available to physicians and patients within about two weeks."

Key Takeaways:

  • The FDA has approved BENLYSTA (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
  • The medication is contraindicated in patients who have had anaphylaxis with belimumab.
  • Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including belimumab.
  • The most frequent serious infections included pneumonia, urinary tract infection (UTI), cellulitis, and bronchitis.
  • Hypersensitivity reactions were reported in 13% of patients receiving belimumab and 11% of patients receiving placebo.
  • Psychiatric events (primarily depression, insomnia, and anxiety) were reported more frequently with belimumab (16%) than with placebo (12%).
  • The most commonly reported adverse reactions (5%) with BENLYSTA were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

Statistics:

  • 14 deaths occurred during the placebo-controlled, double-blind treatment periods: 3/675 (0.4%), 5/673 (0.7%), 0/111 (0%), and 6/674 (0.9%) deaths in the placebo, belimumab 1 mg/kg, belimumab 4 mg/kg and belimumab 10 mg/kg groups, respectively.
  • Serious infections occurred in 6.0% of patients treated with belimumab and in 5.2% of patients who received placebo.
  • Hypersensitivity reactions were reported in 13% of patients receiving belimumab and 11% of patients receiving placebo.
  • Psychiatric events were reported in 16% of patients receiving belimumab and 12% of patients receiving placebo.

Sources:

  • Human Genome Sciences, Inc.
  • GlaxoSmithKline PLC
  • US Food and Drug Administration (FDA)

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