Extract to table

215-847, the resulting approved labeling must be internally consistent across both the RA and psoriasis indications

This coordination requirement applies to all sections of the USPI but is most critical with respect to the following: First, the boxed Warning (currently addressing serious infections, malignancies, major adverse cardiovascular events ("MACE"), and thrombosis, consistent with FDA's September 2021 class-wide JAK-inhibitor labeling update) must be consistent across both indications

Second, the Warnings and Precautions section (Section 5 of the USPI) must harmonize any psoriasis-specific safety language with the existing RA-specific language

It is critical to note that both co-primary endpoints must be met in CLARION-3 to support filing of the sNDA

Both co-primary endpoints must be met for the study to serve as the confirmatory trial

FDA was unambiguous at the Type B meeting that both co-primary endpoints must be met in the confirmatory study, and that the sNDA must be supported by two adequate and well-controlled Phase III trials