UCB Obtains FDA Approval for Treatment of Plaque Psoriasis After Regulatory Setbacks | BioSpace

Pictured: A woman scratches skin lesions on her elbow/iStock, helivideo

The FDA on Wednesday approved UCB’s bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. The treatment will be sold under the Bimzelx brand.

Bimzelx is a humanized IgG1 monoclonal antibody that acts by targeting IL-17A and IL-17F, two central players in the inflammatory cascade. Bimzelx is the first FDA-approved plaque psoriasis drug that inhibits both cytokines, according to UCB’s announcement.

We know that perfectly clear skin is valued by people with psoriasis, Emmanuel Caeymaex, executive vice president of immunology solutions at UCB, said in a statement, adding that the approval of Bimzelx can help raise the level of care for this disease.

With BIMZELX now approved for psoriasis, we will move quickly to submit applications for additional indications in the United States, Caeymaex said.

Bimzelx is administered using a prefilled syringe or single-dose 160 mg/mL auto-injector, and its approval covers adult patients who are also candidates for routine therapy or phototherapy. Its label does not have a boxed warning but contains precautions against suicidal ideation and behavior, infections, inflammatory bowel disease, tuberculosis, and liver biochemistry abnormalities.

UCB supported its application to the FDA with data from three phase III studies. The first, called BE VIVID, compared Bimzelx to placebo and J&Js Stelara (ustekinumab). Meanwhile, the BE READY trial used a placebo as a comparator, while the BE SURE trial pitted Bimzelx against AbbVies Humira (adalimumab).

Taken together, data from these three studies showed that Bimzelx can induce higher levels of skin clearance than placebo, Stelara and Humira. Notably, more than 80% of treated patients achieved clear or near-clear skin, defined by at least a 90% improvement in the Psoriasis Area and Severity Index (PASI).

Complete skin clearance, defined as 100% improvement in PASI, was observed in approximately 60% of patients treated with Bimzelx.

Wednesday’s approval is the culmination of a long and somewhat difficult regulatory path for Bimzelx. In October 2021, UCB reported that the FDA had to delay its verdict on the biologics license application for antibodies because the regulator was unable to conduct on-site inspections of facilities due to regulatory restrictions. travel related to coronavirus.

In May 2022, the delay ended with a comprehensive response letter, with the FDA highlighting pre-approval inspection observations that the company needed to address before the application could be reconsidered.

Bimzelx’s approval is UCB’s second regulatory victory this week. The biopharmaceutical company won another nod from the FDA on Tuesday for its subcutaneous complement C5 inhibitor, zilucoplan, now marketed as Zilbrysq, for the treatment of generalized myasthenia gravis.

Tristan Manalac is a freelance science writer based in Metro Manila, Philippines. He can be contacted at tristan@tristanmanalac.com or tristan.manalac@biospace.com.