1. Scrip
  2. >>New Products

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

Launches To Follow In A Month, Late 2023

 
• By Mandy Jackson

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.

The Belgian pharma firm ended 2022 with €5.52bn in revenue, down 4% from 2021, and UCB expects its 2023 revenue...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 
• By Edwin Elmhirst

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Scrip and Pink Sheet journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By Joseph Haas

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Kymera Inks CDK2 Deal With Gilead

 
• By Alaric DeArment

Deal Snapshot: The biotech will receive up to $750m from Gilead for molecular glue degraders against CDK2.