Oct. 18 Quick Takes: FDA approves UCB’s Bimzelx and Zilbrysq

UCB S.A. (Euronext:UCB) received two FDA approvals in the past two days after the U.S. agency approved Bimzelx bimekizumab and Zilbrysq zilucoplan. Bimzelx, IL-17A and IL-17F inhibitor, is approved for plaque psoriasis, with the Belgian biopharma expecting peak sales of €4 billion ($4.2 billion). The molecule is also under review for hidradenitis suppurativa (HS), with positive Phase III data reported earlier this year. Zilbrysq is UCB’s second approval this year to treat generalized myasthenia gravis, following the June approval of FCRN inhibitor Rystiggo rozanolixizumab. The label for the once-daily subcutaneous C5 inhibitor includes a black box warning for a risk of serious meningococcal infections.

FDA approved Xphozah tenapanor from Ardelyx Inc. (NASDAQ:ARDX) to reduce serum phosphate in dialysis-dependent patients with chronic kidney disease who respond inadequately to or cannot tolerate phosphate binders. The biotech had appealed a 2021 complete response letter from the agency; the SLC9A3 inhibitor received two positive votes from an FDA advisory committee in November 2022...