COPD Market Poised for ‘Paradigm Shift’ with Potential Approvals in 2024: GlobalData

2024-03-27

临床3期上市批准优先审批临床结果

Pictured: Illustration of lungs with syringes/Nicole Bean for BioSpace Potential FDA approvals this year of Sanofi and Regeneron’s Dupixent (dupilumab), as well as Verona Pharma’s ensifentrine, could change the treatment paradigm for chronic obstructive pulmonary disease, according a new report from analytics firm GlobalData. Dupixent is poised to address the notable gap in biologic treatments for chronic obstructive pulmonary disease (COPD) and target its underlying inflammatory pathway by blocking the IL-3 and IL-4 cytokines, according to the analysis. Meanwhile, Verona’s ensifentrine introduces a new mechanism by inhibiting both the phosphodiesterase 3 and 4 enzymes to ease exacerbations. “The COPD late-stage market looks extremely promising,” GlobalData pharma analyst Asiyah Nawab said in a statement, adding that their modes of action and promising clinical data could facilitate their “penetration into the market this year.” According to COPD experts interviewed by GlobalData, “the pipeline for COPD is extremely positive, with Sanofi/Regeneron’s Dupixent and Verona’s Ensifentrine having a high chance of being licensed.” The experts also noted that the COPD space “has not been in this position for decades.” Sanofi and Regeneron’s Dupixent—currently approved for atopic dermatitis, asthma, prurigo nodularis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps—is a monoclonal antibody that blocks the IL-3 and IL-4 cytokines reducing type 2 inflammation, a key driver in several immune-mediated conditions. The partners are proposing Dupixent as a COPD treatment using results from the Phase III BOREAS and NOTUS trials. Data from BOREAS, published in May 2023, demonstrated that adding Dupixent to standard of care could reduce moderate or severe exacerbations by 30% over 52 weeks. The therapeutic antibody could also boost lung function and health-related quality of life while lowering symptom severity. In NOTUS, Dupixent reduced moderate or severe acute exacerbations by 34% over 52 weeks of follow-up, while also improving lung function. The FDA in February 2024 accepted the supplemental Biologics License Application for Dupixent and granted it Priority Review. The decision is due by June 27, 2024. Verona’s ensifentrine is also undergoing regulatory review. The FDA accepted its New Drug Application in September 2023 and has set a target action date of June 26, 2024. Ensifentrine is backed by data from the Phase III ENHANCE trials, which found that the candidate reduced the risk of COPD exacerbations while also improving lung function and easing symptoms. In January 2024, Verona secured $400 million in financing from Oxford Finance and Hercules Capital, which the biotech will use to fund the launch of ensifentrine. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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