UCB’s Psoriasis Drug’s FDA Application on Pause Due to Facility Inspection Issues

The US Food and Drug Administration (FDA) has temporarily halted the approval process for UCB’s psoriasis drug bimekizumab on concerns with facility inspections. This is the second delay UCB has faced thus far related to inspections, with the agency postponing the company’s application last October due travel restrictions caused by COVID. The company is currently working with the agency to solve the problem.

According to James Waldron of Fierce Pharma, “The rejection marks another frustrating obstacle for the Belgian biotech’s drug, which beat Johnson & Johnson’s Stelara in a phase 3 psoriasis trial in 2020. Over the past 10 months, bimekizumab has received marketing authorization for plaque psoriasis in the EU, Great Britain, Japan, Canada and Australia, the company pointed out.”

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(Source: Fierce Pharma, May 13^th, 2022)