Belimumab: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Belimumab appears in the FDA drug-label database. Marketed as BENLYSTA.

Drug class

B Lymphocyte Stimulator-specific Inhibitor (FDA established pharmacologic class)

Mechanism of action

B Lymphocyte Stimulator-directed Antibody Interactions (as stated on the FDA label)

FDA-approved use

BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation. BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy; ( 1 ) • Active lupus nephritis who are receiving standard therapy. ( 1 ) Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system lupus. Use of BENLYSTA is not recommended in this situation. ( 1 )

FDA recalls / enforcement

FDA label via openFDA