FDA action is no longer expected in Q3 of 2023.
This article was originally published by Dermatology Times. It has been lightly edited.
UCB has announced that it has received an Establishment Inspection Report from the FDA after a prelicense inspection conducted at its Belgium manufacturing facility in April 2023 regarding the production of Bimzelx (bimekizumab) for the treatment of adult patients with moderate to severe plaque psoriasis. The FDA has stated that the inspection is “successfully closed.”1
The FDA will continue to review UCB’s bimekizumab Biologics License Application (BLA) but has not provided any further details on a new timeline to take action. UCB no longer anticipates FDA action in Q3 of 2023.
As UCB waits for further details on bimekizumab’s approval, it will continue to work with the FDA to complete the full review of bimekizumab’s BLA and its label. According to UCB, “The next update for the bimekizumab BLA will be shared at the time of the FDA action. UCB’s previously communicated 2023 financial guidance range remains unchanged.”
In March of 2022, the FDA issued a complete response letter to UCB regarding it BLA for bimekizumab and stated that “it cannot approve the BLA in its current form.” At the time, preapproval inspection observations were made during the approval process that needed to be resolved before moving forward.2
In early 2021, the FDA gave UCB a Prescription Drug User Fee Act date of October 15, 2021,3 but then delayed the approval due to needing an on-site facility inspection, and the COVID-19 pandemic restricted travel to and inspections of the Belgium facility.4
References
1. UCB provides update on US regulatory review of bimekizumab. News release. UCB. September 20, 2023. Accessed September 20, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Provides-Update-on-US-Regulatory-Review-of-Bimekizumab
2. Update on US FDA review of biologics license application (BLA) for bimekizumab. News release. UCB. May 13, 2023. Accessed September 20, 2023. https://www.ucb.com/stories-media/Press-Releases/article/Update-on-US-FDA-Review-of-Biologics-License-Application-BLA-for-bimekizumab-0
3. UCB announces PDUFA date for bimekizumab. News release. UCB. April 28, 2021. Accessed September 20, 2023. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-pdufa-date-bimekizumab
4. FDA misses PDUFA date for bimekizumab. Formulary Watch. October 19, 2021. Accessed September 20, 2023. https://www.formularywatch.com/view/fda-misses-pdufa-date-for-bimekizumab
Integrating RECIST and Clinician Approaches Boosts NSCLC Research
May 8th 2024Outcomes among patients with stage IV non–small cell lung cancer as evaluated within clinical trials via Response Evaluation Criteria in Solid Tumors (RECIST) and clinician response criteria in observational studies were compared for their concordance and reliability.
Read More
CMS Medicare Final Rule: Advancing Benefits, Competition, and Consumer Protection
May 7th 2024On this episode of Managed Care Cast, we're talking with Karen Iapoce, senior director of government products and programs at ZeOmega, about the recent CMS final rule on Medicare Part D and Medicare Advantage.
Listen
Navigating Health Policy in an Election Year: Insights From Dr Dennis Scanlon
April 2nd 2024On this episode of Managed Care Cast, we're talking with Dennis Scanlon, PhD, the editor in chief of The American Journal of Accountable Care®, about prior authorization, price transparency, the impact of health policy on the upcoming election, and more.
Listen
Coexistence of HIV, Hemophilia May Lead to Increased Presence of Coronary Artery Stenosis
May 8th 2024In patients living with HIV, the cardiovascular risk factors that come with infection may lead to an increased prevalence of coronary artery stenosis, especially in those who also have hemophilia.
Read More
The Joint Commission is launching the Rural Health Clinic Accreditation Program to standardize staff training and patient care practices at rural health clinics nationwide; the American Cancer Society recently launched the largest-ever study of cancer risk and outcomes in Black women; the HHS COVID-19 vaccination campaign saved $732 billion by preventing illness and related costs.
Read More