March 17 Quick Takes: FDA extends review of Rinvoq in psoriatic arthritis; plus Merck, PharmaEssentia, Lilly, Roche and more

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review of an sNDA for Rinvoq upadacitinib to treat adult patients with active psoriatic arthritis after the agency had requested additional information on the oral JAK-1 inhibitor’s risk-benefit profile; a decision is now expected in late 2Q21.

The company said it is also preparing to submit additional information at FDA’s request to support its sNDA for Rinvoq to treat atopic dermatitis. Phase III data reported in October suggested Rinvoq has the edge in efficacy in the indication versus three other Phase III programs and Dupixent dupilumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NASDAQ:SNY)...