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The authorisation triggered an milestone payment from Janssen Biotech, Inc. to MorphoSys AG (Martinsried, Germany), which had discovered and licenced the first ever approved IL23-blocking antibody to treat moderate to severe plaque psoriasis to the US company. The approval of the immunosuppressive antibody, which will be sold under the tradename Tremfya, comes after an expedited regulatory review following application of an FDA Priority Review Voucher.
In the pivotal studies VOYAGE 1 and VOYAGE 2, the subcutanously administered antibody proved to be superior to standard of care (adalimumab) in PASI 90 after 16-48 weeks of treatment. Improvements…