AbbVie Gets CHMP Positive Opinion for Risankizumab in Psoriatic Arthritis
October 15 2021 - 9:19AM
Dow Jones News
By Michael Dabaie
AbbVie said the European Medicines Agency's Committee for
Medicinal Products for Human Use recommended the approval of
risankizumab alone or in combination with methotrexate for the
treatment of active psoriatic arthritis.
The recommendation covers adults who have had an inadequate
response or who have been intolerant to one or more
disease-modifying antirheumatic drugs. The CHMP positive opinion is
a scientific recommendation for marketing authorization to the
European Commission, which authorizes marketing approval in the
EU.
The CHMP positive opinion was supported by data from two pivotal
Phase 3 studies.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 15, 2021 09:04 ET (13:04 GMT)
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