UCB Wins Two Key US Approvals: Bimzelx In Psoriasis, Zilbrysq In gMG

Launches To Follow In A Month, Late 2023

Oct 19 2023

• By Mandy Jackson

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Two years after its first FDA review, UCB’s next blockbuster Bimzelx finally crossed the finish line. Supplemental filings for more indications will soon follow as the company forecasts €4bn in peak sales.

Night speedy motion blur international race track with starting finishing line and confetti — Bimzelx crossed the US finish line after a lengthy delay • Source: Shutterstock

UCB S.A. won US Food and Drug Administration approval for two key products needed to help the company return to growth – Bimzelx (bimekizumab-bkzx) for adults with moderate-to-severe plaque psoriasis on 18 October and Zilbrysq (zilucoplan) for adults with generalized myasthenia gravis (gMG) on 17 October. Bimzelx will launch in a month and Zilbrysq will be available around the end of 2023, but both are expected to be big contributors to UCB’s goal of achieving €6bn in annual revenue by 2025.

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