April 5 Quick Takes: FDA extends review of Rinvoq in atopic dermatitis; plus Acadia, Supernus

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review for an sNDA for Rinvoq upadacitinib to treat moderate to severe atopic dermatitis following the agency’s request for an updated assessment of the oral JAK-1 inhibitor’s benefit-risk profile. A decision is now expected in 3Q21.

Phase III data reported in October suggested Rinvoq has the edge in efficacy in the indication versus three other Phase III programs as well as marketed drug Dupixent dupilumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NASDAQ:SNY)...