FDA Approves GlaxoSmithKline's Treatment for Pediatric Patients with Lupus
April 26 2019 - 4:31PM
Dow Jones News
By Stephen Nakrosis
The U.S. Food and Drug Administration on Friday said it approved
GlaxoSmithKline PLC's (GSK) Benlysta, or belimumab, intravenous
infusion to treat children with systemic lupus erythematosus,
commonly known as lupus.
This is the first time the administration approved a treatment
for pediatric patients with lupus, it said. Benlysta has been
approved for use in adult patients since 2011.
The FDA said childhood-onset SLE is rare, but is generally more
active in children and adolescents than adult patients. As a result
of the disease starting early in life, pediatric patients have a
higher risk for developing increased organ damage and complications
from the disease.
Dr. Hal Barron, Chief Scientific Officer and President, R&D,
at Glaxo, said, "Children with lupus have had limited options
available to help treat their condition. This accelerated decision
means children in the U.S. now have an innovative, FDA-approved
medicine available to help manage the impact of living with this
challenging autoimmune disease."
"The agency expedited the review and approval of this
application because Benlysta IV fulfils an unmet need for
therapies, specifically in pediatric patients with SLE. While there
is no cure for lupus, treatment can help our youngest patients
control their disease with the hope of improving their quality of
life and lowering their risk of long-term organ damage and
disability," said Janet Woodcock, M.D., director of the FDA's
Center for Drug Evaluation and Research.
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 26, 2019 16:16 ET (20:16 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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