FDA Approves Benlysta for Treatment of Systemic Lupus Erythematosus

Strategic Insights -

The US Food and Drug Administration (FDA) Arthritis Advisory Committee has recommended approval for Benlysta (belimumab) to treat autoantibody-positive patients with active systemic lupus erythematosus. This development is a significant milestone for patients suffering from this debilitating autoimmune disease. The FDA has set a target date of December 9, 2010, for its decision, and if approved, Benlysta will be the first drug in its class, BLyS-specific inhibitors, to be marketed.

Key Takeaways:

  • The FDA Arthritis Advisory Committee has voted to recommend approval for Benlysta (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus.
  • Benlysta is an investigational drug developed by Human Genome Sciences Inc and GlaxoSmithKline PLC under a co-development and co-commercialisation agreement.
  • The companies will share equally in Phase III/IV development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.
  • Human Genome has responsibility for conducting the belimumab Phase III trials, with assistance from GlaxoSmithKline.
  • GlaxoSmithKline PLC is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
  • Human Genome Science Inc's mission is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

Statistics:

  • The FDA has assigned Benlysta a Prescription Drug User Fee Act target date of December 9, 2010.
  • Belimumab is the first in a new class of drugs called BLyS-specific inhibitors.
  • The drug is being developed for the treatment of autoantibody-positive patients with active systemic lupus erythematosus.

Sources:

  • "Human Genome Sciences and GlaxoSmithKline Announce Positive Vote by FDA Arthritis Advisory Committee for Belimumab" [Source not explicitly provided in the original text]