Regeneron, Sanofi Get Positive CHMP Opinion for Dupixent
20 September 2019 - 9:22PM
Dow Jones News
By Chris Wack
Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) said
Friday the European Medicines Agency's Committee for Medicinal
Products for Human Use has adopted a positive opinion for Dupixent
dupilumab in a third indication.
The companies said CHMP recommended Dupixent be approved as an
add-on therapy with intranasal corticosteroids for the treatment of
adults with severe chronic rhinosinusitis with nasal polyposis for
whom therapy with systemic corticosteroids and/or surgery don't
provide adequate disease control.
If approved, Dupixent would be the first biologic medicine
available in the European Union to treat these patients.
Regeneron and Sanofi said the positive CHMP opinion is based on
two pivotal Phase 3 trials that evaluated Dupixent 300 mg every two
weeks plus standard-of-care intranasal corticosteroids compared to
placebo plus intranasal corticosteroids. A final decision on the
Dupixent application by the European Commission is expected in the
coming months.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2019 07:07 ET (11:07 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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