J&J Unit Seeks FDA OK for Simponi Aria in Juvenile Indications
April 24 2020 - 10:26AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson's Janssen Pharmaceutical Cos. unit on
Friday said it is seeking U.S. Food and Drug Administration
approval of its arthritis drug Simponi Aria in a pair of juvenile
indications.
The drug maker said it filed supplemental biologics license
applications for the drug for the treatment of polyarticular
juvenile idiopathic arthritis and juvenile psoriatic arthritis in
patients two years of age and older in combination with
methotrexate.
Janssen said Simponi Aria, if approved for the indications,
would be the first anti-tumor necrosis factor-alpha biologic agent
administered by intravenous infusion available for such juvenile
patients.
The FDA previously approved Simponi Aria for adults with
moderately to severely active rheumatoid arthritis, active
psoriatic arthritis and active ankylosing spondylitis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 24, 2020 10:11 ET (14:11 GMT)
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