UCB PHARMA SA

Authors are members of the Therapies Scientific Committee of IRDiRC. R. K. is employed by Certara, T. M. by UCB Pharma, and D. O.'C. by ABPI. Views are personal, not institutional.

The FcRn inhibitor market report by ResearchAndMarkets.com provides insights into historical and competitive landscapes, market trends, emerging drugs, and forecasts from 2020 to 2034. Key players like Johnson & Johnson, UCB Biopharma, Pfizer, and Immunovant are developing FcRn inhibitors for autoimmune diseases. Prominent drugs include VYVGART, RYSTIGGO, and batoclimab, with positive trial results and FDA approvals. The market is expected to grow due to increasing diagnoses and emerging therapies.

Korea UCB Pharma secured South Korean approval for Bimzelx (bimekizumab) for plaque psoriasis and Zilbrysq (zilucoplan) for myasthenia gravis in 2023. The company aims to expand its portfolio in 2024 with anticipated approvals for Fintepla (fenfluramine) for Dravet and Lennox-Gastaut syndromes, and Rystiggo (rozanolixizumab) for myasthenia gravis. Bimzelx is poised to compete in Korea's plaque psoriasis market with superior efficacy and safety.

The FDA approved bimekizumab for moderate to severe hidradenitis suppurativa, based on BE HEARD trials. Bimekizumab, an IL-17A/IL-17F inhibitor, addresses unmet needs by offering more complete inflammation blockade than IL-17A alone, leading to sustained improvements in symptoms. The open-label extension study showed continued efficacy and safety over 2 years, with 40% achieving no abscesses or inflammatory nodules.

Early trials of antisense oligonucleotide (ASO) treatments for rare genetic epilepsies show promise in reducing seizures, but high costs pose challenges. ASOs have grown from a single N-of-1 study in 2019 to involve over two dozen patients, with some trials reporting significant seizure reductions. Despite promising results, the high cost of ASO treatments, potentially in the millions, raises concerns about accessibility. Neurologists emphasize the need for genetic screening at birth to identify patients early and streamline the development of these gene-based therapies.

FDA approves UCB SA's Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa in adults, marking the first IL-17A and IL-17F inhibitor. Phase 3 studies BE HEARD I and II showed significant improvements in HiSCR50 and HiSCR75 at Week 16, with sustained responses to Week 48.

FDA approves bimekizumab for moderate to severe hidradenitis suppurativa, adding to its 5 US indications in 13 months, supported by BE HEARD trials and positive long-term data.

Sarilumab more effective than methotrexate in enabling steroid taper in polymyalgia rheumatica patients, according to ACR Convergence 2024 data.

UCB Pharma's bepranemab, a monoclonal antibody targeting tau, shows potential in slowing tau pathology in Alzheimer's patients with low baseline tau levels and no ApoE4, suggesting a new treatment strategy. Researchers highlight tau seeding's role in disease progression, and ongoing trials aim to optimize treatment timing and population selection.

Global exosome market to grow at ~20% CAGR by 2030, driven by chronic disease incidence, diagnostic improvements, and personalized medicine interest. North America leads, with key players like Danaher and Thermo Fisher Scientific. Notable developments include Aruna Bio's US patent for neural exosomes and EXO Biologics' EUR 16 million Series A funding.