FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis

Follow Drugslib on

By Lori Solomon HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on July 1, 2025.

via HealthDay

MONDAY, June 30, 2025 -- The U.S. Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy.

Benlysta (200 mg/mL), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, is the first and only approved biologic for both systemic lupus erythematosus and lupus nephritis. It is not recommended in patients with severe active central nervous system lupus.

The most common major adverse reactions seen with Benlysta were serious infections, some of which were fatal. The most common adverse reactions (≥5 percent) were nausea, diarrhea, fever, inflammation of the nasal passages and throat, bronchitis, insomnia, pain in extremity, depression, migraine, and injection site reactions.

"In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child's growth and quality of life," Louise Vetter, president and CEO of the Lupus Foundation of America, said in a statement. "Having the Benlysta autoinjector provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering continuity of care and routines of daily life."

Approval of Benlysta was granted to GSK.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-07-01 12:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords