J&J's Janssen Seeks FDA OK of Tremfya in Active Psoriatic Arthritis
September 16 2019 - 8:16AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit
on Monday said it filed a supplemental biologics-license
application with the U.S. Food and Drug Administration seeking
first-in-class approval of Tremfya for adults with active psoriatic
arthritis.
Janssen said it also expects to submit a marketing application
to the European Medicines Agency for the same indication before the
end of the year.
The company said it is estimated that at least one million
Americans suffer from psoriatic arthritis, chronic disease
characterized by joint inflammation, enthesitis, dactylitis and the
skin manifestations of psoriasis.
The FDA approved Tremfya in July 2017 for adults with moderate
to severe plaque psoriasis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 16, 2019 08:01 ET (12:01 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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