FDA clears UCB’s Bimzelx for psoriasis treatment
The US Food and Drug Administration (FDA) has approved UCB’s BIMZELX (bimekizumab) to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimzelx is a monoclonal antibody designed to attach to interleukins IL-17A, IL-17F and IL-17AF. High levels of these interleukins have been linked to inflammatory diseases caused by the immune system such as plaque psoriasis. Bimzelx inhibits these interleukins, reducing inflammation. The approval of Bimzelx is based on three Phase III studies: BE VIVID (NCT03370133), BE READY (NCT03410992) and BE SURE (NCT03412747). The studies tested the safety and efficacy of Bimzelx against different comparators. While BE VIVID pitted Bimzelx against placebo and Johnson & Johnson’s Stelara (ustekinumab), BE READY only featured a placebo comparator. Finally, BE SURE included Abbvie’s Humira (adalimumab) as the comparator. After 16 weeks, 85%-91% of patients treated with BIMZELX in the Phase III studies achieved a clear or almost clear skin, based on the 18 October press release. Upper respiratory infections, oral candidiasis and headaches were some of the most common adverse reactions. Bimzelx is available as an autoinjector and a pre-filled syringe and may be administered by a healthcare professional or by the patient themselves after training. UCB has announced that Bimzelx will be available in the US in approximately one month. According to GlobalData’s Pharma Intelligence Centre, a sales consensus forecasts, Bimzelx to have global sales of $2.8bn by 2029. Bimzelx's competitor Stelara made $9.7bn in sales last year, per J&J’s 2022 annual report. GlobalData forecasts that this will drop to $2.2bn by 2029. GlobalData is the parent company of Pharmaceutical Technology. In June, the FDA approved UCB’s Rystiggo (rozanolixizumab) for the treatment of generalised myasthenia gravis (gMG). In October 2019, UCB announced its plans to acquire Ra Pharmaceuticals for $2.5bn, which also added the gMG drug zilucoplan to its portfolio. On 17 October, the FDA approved zilucoplan, now marketed as ZILBRYSQ, for use in adults with gMG who are anti-acetylcholine receptor antibody-positive.
UCB’s drug is the first IL-17A and IL-17F inhibitor approved for patients with moderate to severe plaque psoriasis.
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