FDA Approves BENLYSTA as a Weekly Self-Administered Injection to Treat Lupus

Today, the U.S. Food and Drug Administration has approved a new subcutaneous formulation of Benlysta (belimumab) for subcutaneous use (SC), providing a new, less invasive method for administering this therapy to treat lupus. This new formulation of Benlysta, produced by GSK, would be the first self-injection lupus treatment that people with lupus can administer at home once per week.  Previously patients receiving Benlysta had to travel to a medical facility for monthly infusions.

Dr. Susan Manzi, Chair of the Department of Medicine of Allegheny Health Network in Pittsburgh, and also Medical Director for the Lupus Foundation of America said, "The new injection formulation of Benlysta will provide a convenient option for our patients who prefer to administer the medication at home instead of taking the time for a one hour infusion at a remote location.  We are always looking for better ways to serve our patients and this is a major step forward."

Benlysta was first approved as a monthly infusion therapy for lupus in March 2011. Patients on this original formulation had to travel to an infusion center to receive the therapy. GSK’s Benlysta SC will be self-administered as a weekly injection into the fatty layer of tissue just under the skin. It will be available as either a single-dose pre-filled syringe or from a single-dose auto-injector.

More information is available from the GSK media release.  GSK will post additional information about Benlysta SC at benlysta.com.