FDA Approves New Option for SLE

The US Food and Drug Administration recently approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. This is the first subcutaneous self-infection treatment option to be approved for patients with SLE. 

Benlysta is administered via a single-dose prefilled syringe or a single-dose autoinjector once a week at a dose of 200 mg. Patients should be trained by a health care provider prior to initiating self-injection treatment.
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Common adverse reactions that occurred in patients who received Benlysta during clinical trials included nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, cystitis, leukopenia, and viral gastroenteritis. In addition, infections, some of which were fatal, occurred in patients who received Benlysta during the trials.

Additionally, patients who have experienced anaphylasix with belimumb should not receive Benlysta.

—Melissa Weiss

Reference:

GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus [press release]. London, UK: GSK; July 21, 2017. https://www.gsk.com/en-gb/media/press-releases/gsk-receives-fda-approval-for-a-new-self-injectable-formulation-of-benlysta-belimumab-for-systemic-lupus-erythematosus/. Accessed July 21, 2017.