FDA Rejects UCB's Bimekizumab for Psoriasis Due to Inspection Observations
核心洞察
The FDA issued a complete response letter for UCB (搜索)'s bimekizumab, citing unresolved observations from FDA inspections, delaying potential approval for moderate-to-severe plaque psoriasis (搜索).
Bimekizumab, known as Bimzelx in Europe, has already been approved in Europe, Japan, Canada, and Australia, and pre-approved for NHS reimbursement in the UK.
UCB (搜索) is evaluating the financial impact of the FDA's decision on its 2022 forecasts, as bimekizumab was expected to compete with established IL-17 inhibitors like Novartis' Cosentyx.
The FDA has declined to approve UCB (搜索)'s bimekizumab for the treatment of moderate-to-severe plaque psoriasis (搜索), delivering a setback to the company's late-stage pipeline. The complete response letter from the FDA stated that the application could not be approved in its current form due to observations made during FDA inspections that need to be addressed. This decision impacts UCB's financial projections for 2022, and the company is currently assessing the extent of the impact. Despite this rejection in the US, bimekizumab has already been approved in Europe (where it is marketed as Bimzelx), Japan, Canada, and Australia.
Bimekizumab's Potential in the IL-17 Inhibitor Market
Bimekizumab is an IL-17A and IL-17F inhibitor, which UCB (搜索) believes gives it an advantage over drugs like Novartis' Cosentyx (secukinumab), which only targets IL-17A. UCB suggests that IL-17F is also a key contributor to chronic tissue inflammation. The drug has demonstrated superior efficacy in head-to-head studies against Cosentyx, achieving complete skin lesion clearance (PASI 100 response) at both 16 and 48 weeks. NICE (UK cost-effectiveness agency) has pre-approved bimekizumab for NHS reimbursement, noting its costs are likely to be similar or lower than Cosentyx and other biologics used for psoriasis (搜索).
Competitive Landscape and Future Prospects
Bimekizumab aims to compete in a crowded market of IL-17 inhibitors, including Eli Lilly's Taltz (ixekizumab) and Bausch Health's Siliq/Kyntheum (brodalumab). Despite the competition, analysts at Jefferies project peak sales of over $2 billion for bimekizumab, contingent on approvals for follow-up indications like psoriatic arthritis (搜索) and ankylosing spondylitis (搜索). These sales are crucial for UCB (搜索), as it faces upcoming patent expiries for its top-selling product, Cimzia (certolizumab pegol), in Europe this year and in the US in 2024. However, other biologics, such as AbbVie (搜索)'s IL-23 inhibitor Skyrizi (risankizumab), have also demonstrated superior performance compared to Cosentyx in clinical trials, adding to the competitive pressure. The market is also seeing emerging oral therapies like TYK2 inhibitors from Bristol Myers Squibb, Pfizer and Nimbus Therapeutics, which could challenge the current injectable antibody treatments. Eli Lilly's decision to withdraw its IL-23 drug mirikizumab from psoriasis (搜索) filing, despite positive trial results against Cosentyx, highlights the increasing congestion and difficulty in this market.