Psoriasis

Bad news for Belgian biotech UCB as FDA rejects its latecomer IL-17 inhibitor bimekizumab for psoriasis, citing a need to resolve "pre-approval inspection ...

The delay to approval means that UCB is reviewing its financial forecasts for 2022, although it hasn’t yet determined what the impact will be. Cimzia sales were €1.8 billion ($1.87 billion) last year. UCB needs that to happen if it is to lessen the impact of forthcoming patent expiries for the Belgian drugmaker’s current top-selling product Cimzia (certolizumab pegol), due in Europe this year and in the US in 2024.

The FDA issued a complete response letter stating a biologics license application for bimekizumab cannot be approved until pre-approval inspection ...

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The rejection appears to be related to pre-approval inspection issues that need to be resolved before it can be approved.

"People living with this disease experience symptoms that are nebulous, fluctuating, and which vary from one day to the next. If that's the case, the only risk for the company would be an additional delay because there is no apparent reference to clinical issues. Bimekizumab was approved in August 2021 in the U.K. and the European Union and in January 2022 in Japan for plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who don't respond to existing treatments. Psoriasis is a chronic inflammatory disease of the skin. It won't be a happy weekend for UCB as the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to the Belgium-based company regarding its Biologics License Application (BLA) for bimekizumab for adults with moderate to severe plaque psoriasis. Company stock dropped 12% at the news.

The FDA cited manufacturing issues in turning down UCB's application seeking approval for bimekizumab, an antibody drug developed to treat ...

Last August, the drug was granted marketing authorization in the European Economic Area and Great Britain as a treatment for moderate-to-severe plaque psoriasis in adults. In January, regulators in Japan approved the drug for treating plaque psoriasis, generalized pustular psoriasis, and psoriatic erythroderma in patients who do not sufficiently respond to earlier lines of treatment. J&J’s Stelara is also an antibody, but that drug is designed to block two other signaling proteins: IL-12 and IL-23. It won its first approval in 2009 for treating adults with moderate-to-severe plaque psoriasis. Plaque psoriasis is the most common form of psoriasis, presenting as darker and thicker patches on the skin that may also be itchy and painful. Bimekizumab is an antibody designed to selectively block IL-17A and IL-17F, two cell signaling proteins that drive the inflammation behind psoriasis. The FDA rejected UCB’s drug application, citing inspection issues with a manufacturing site.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to UCB for its Biologics License Application (BLA) for bimekizumab as ...

Data from earlier this week showed adults with moderate to severe psoriasis treated with bimekizumab over 2 years reported good tolerance and a favorable safety profile. “So, we're seeing a lot more excitement in psoriasis than we were expecting, even decades after we saw our first biologic.” The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to UCB for its Biologics License Application (BLA) for bimekizumab as a potential treatment of moderate to severe plaque psoriasis.

UCB will review its full-year financial guidance in light of the agency's decision on its drug, bimekizumab.