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Pharmaceutical industry

First New Approved Drug for Systemic Lupus in Over 50 Years

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has approved Benlysta (belimumab), the first new drug for systemic lupus in over 50 years. Developed by Human Genome Sciences (HGS) in collaboration with GlaxoSmithKline (GSK), Benlysta is a BLyS-specific inhibitor that targets B cells, which play a key role in the autoimmune disease.

Systemic lupus erythematosus (SLE) is a chronic and complex disease that affects millions of people worldwide. Despite the availability of treatments, many patients experience inadequate responses to current therapies, highlighting the need for new and effective treatments. Benlysta has been shown to be effective in reducing disease activity and improving patients' quality of life.

Key Takeaways:

  • Benlysta (belimumab) is the first new approved drug for systemic lupus in over 50 years.
  • Developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK), Benlysta is a BLyS-specific inhibitor that targets B cells.
  • Benlysta has been shown to be effective in reducing disease activity and improving patients' quality of life.
  • The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
  • Use of Benlysta is not recommended in these situations.
  • Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including Benlysta.
  • Psychiatric events, including depression, insomnia, and anxiety, were reported more frequently with Benlysta than with placebo.
  • The most commonly reported adverse reactions (5%) with Benlysta were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.
  • Benlysta is expected to be available to physicians and patients within about two weeks.

Statistics:

  • 14 deaths occurred during the placebo-controlled, double-blind treatment periods in clinical trials of Benlysta.
  • 2133 patients participated in the 3 clinical trials of Benlysta.
  • 6.0% of patients treated with Benlysta experienced serious infections.
  • 5.2% of patients who received placebo experienced serious infections.
  • 13% of patients receiving Benlysta reported hypersensitivity reactions.

Sources:

  • Human Genome Sciences, Inc. (HGS). (n.d.). HGS Announces FDA Approval of Benlysta (Belimumab) for Systemic Lupus Erythematosus.
  • GlaxoSmithKline PLC (GSK). (n.d.). GSK and HGS Announce FDA Approval of Benlysta (Belimumab) for Systemic Lupus Erythematosus.
  • US Food and Drug Administration (FDA). (n.d.). FDA Approves Benlysta (Belimumab) for the Treatment of Systemic Lupus Erythematosus.
  • Human Genome Sciences, Inc. (HGS). (n.d.). Benlysta (Belimumab) Prescribing Information.

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