It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. Now with a new nod in hidradenitis suppurativa (HS), the drug seems to be carving the path to blockbuster land with five approved indications.
Bimzelx, which is the first to selectively inhibit IL-17F as well as IL-17A, was cleared to treat adults with moderate to severe forms of the disease after proving it could help patients significantly reduce signs and symptoms of the condition. HS is characterized by chronic and recurring painful nodules, abscesses and pus-discharging fistulas that can have a major impact on quality of life.
UCB is “thrilled” with the milestone, head of patient impact and chief commercial officer Emmanuel Caeymaex said in a company press release.
“This is the fifth patient population who may benefit from Bimzelx, representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases,” the executive added.
The nod comes on the tail of a triple hitter FDA approval that greenlit the drug in active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis. With the handful of indications under its belt, Bimzelx could be on its way to meeting the company’s stated peak sales expectations of at least 4 billion euros ($4.4 billion).
Over the first half of the year, Bimzelx quickly became one of the company’s top sales drivers with 215 million euros ($226 million) in revenue. By July, the med had reached more than 35,000 patients globally, CEO Jean-Christophe Tellier commented in UCB’s half-year financial report.
Tellier christened the drug as a “tremendous value proposition” with a “best-in-disease” profile in an interview last year. The speedy approvals across new indications could be chalked up to the FDA’s initial delayed psoriasis decision in 2021 allowing time to collect the required data in other diseases, Tellier pointed out.
Beyond the sales potential, UCB maintains that Bimzelx is a “critical drug for patients to be able to live their life,” Lee said. HS, for one, is an “extraordinarily painful” disease with a lengthy diagnosis process and few treatment options, UCB’s head of U.S. immunology Camille Lee said in an interview with Fierce Pharma earlier this year.
“When you listen to a patient, it’s hard to walk away without tears, to understand what that journey has been for them,” Lee explained.
While the treatment landscape for some of Bimzelx’s disease areas are rife with competition, AbbVie’s off-patent Humira was the only biologic treatment cleared for use in HS before Novartis’ Cosentyx entered the picture last year.
Despite beating UCB to the chase in the commercial market, SVB analysts at the time described Bimzelx’s phase 3 data drop as “incrementally better than” Cosentyx, suggesting that Novartis could have reason to sweat.