FDA Advisory Committee Recommends Approval of BENLYSTA for Treating Systemic Lupus Erythematosus

Strategic Insights -

The Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend the approval of BENLYSTA (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE). This decision comes after a thorough review of the clinical trial data submitted by the drug's developers, Human Genome Sciences, Inc. (HGS) and GlaxoSmithKline PLC (GSK). The FDA will now consider the committee's non-binding recommendation when making its final decision on the approval of BENLYSTA.

Key Takeaways:

  • The Arthritis Advisory Committee provided a non-binding recommendation for the approval of BENLYSTA, a new class of drugs called BLyS-specific inhibitors, for the treatment of autoantibody-positive SLE patients.
  • The committee's recommendation was made after reviewing the clinical trial data submitted by HGS and GSK, which included data from Phase 3 trials.
  • HGS and GSK are developing belimumab under a co-development and co-commercialization agreement, with HGS responsible for conducting the Phase 3 trials and GSK providing assistance.
  • The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
  • HGS and GSK are committed to improving the quality of human life by enabling people to do more, feel better, and live longer.
  • HGS is focused on applying great science and great medicine to bring innovative drugs to patients with unmet medical needs.
  • The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of December 9, 2010.

Statistics:

  • The FDA Arthritis Advisory Committee voted 13 to 2 to recommend the approval of BENLYSTA.
  • Human Genome Sciences and GlaxoSmithKline are developing belimumab under a co-development and co-commercialization agreement.
  • The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
  • HGS is responsible for conducting the Phase 3 trials, with assistance from GSK.
  • The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of December 9, 2010.

Sources:

  • Rockville, Md., & London -- Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK)
  • U.S. Food and Drug Administration (FDA)
  • Human Genome Sciences, Inc. (HGS)
  • GlaxoSmithKline PLC (GSK)