The European Medicines Agency (EMA) has recently approved Dupixent, a drug developed by Sanofi and Regeneron Pharmaceuticals, as the first biologic therapy for adults with uncontrolled chronic obstructive pulmonary disorder (COPD) characterized by elevated blood levels of eosinophils, a type of white blood cell. This marks a significant development in the treatment for COPD, particularly for cases not sufficiently controlled by existing therapies and where inhaled corticosteroids are deemed inappropriate.
Dupixent, chemically an antibody, functions distinctly from typical anti-inflammatory medications by not suppressing the immune system. Instead, it targets and blocks interleukin-4 (IL-4) and interleukin-13 (IL-13), which are cytokines involved in inflammatory pathways. Initially approved in 2017 for treating atopic dermatitis, Dupixent has since been approved for other immunological conditions including asthma. This range of approvals underscores its effectiveness across various inflammation-driven diseases, despite previous skepticism about its efficacy in treating COPD. This skepticism stemmed from the failure of other biologics in managing COPD, such as AstraZeneca’s Fasenra and GSK’s Nucala, both of which did not succeed in Phase 3 trials specifically for COPD, though they were effective in treating asthma.
Prior to the development of Dupixent, the most recent innovative treatment was the approval of roflumilast in 2011, an oral drug that inhibits the PDE-4 enzyme to reduce inflammation, marketed as Daliresp. This drug represented the latest significant advancement in COPD treatment until now, highlighting a long period without major therapeutic breakthroughs in the field. Paul Rowe, head of medical affairs specialty care North America at Sanofi, emphasized the historical lack of innovation in COPD treatments, recalling years where the primary management strategy was to prescribe an inhaler with minimal follow-up.
The approval of Dupixent by the EMA was underpinned by the data from two Phase 3 clinical trials involving 1,874 individuals, either current or former smokers, with moderate-to-severe COPD and evidence of type 2 inflammation. These double-blind, placebo-controlled studies demonstrated that regular subcutaneous injections of Dupixent every two weeks for a year reduced disease exacerbations by at least 30%, improved lung function, and enhanced overall quality of life. Complete findings from these studies have been published in the New England Journal of Medicine.
This EMA approval came closely after the U.S. Food and Drug Administration (FDA) approved another innovative COPD drug, Ohtuvayre by Verona Pharma, which targets a different mechanism by inhibiting PDE-3 and PDE-4 enzymes. While awaiting FDA’s decision on Dupixent, which is expected by late September after a request for more clinical data, the drug continues to show promise in not only respiratory disorders but also in potentially treating several inflammatory skin conditions, with late-stage trials currently ongoing.
The success of Dupixent in multiple indications has contributed significantly to Sanofi’s revenues, with the drug generating over €10.7 billion globally in the previous year. This success is central to CEO Paul Hudson’s vision for Sanofi to lead in the field of immunology. Dupixent’s role in managing type 2 inflammation—a recent and evolving understanding in immunology—highlights its potential applicability across a broader spectrum of immunological diseases beyond those it is currently approved for.
This development represents a potential shift in the management and perception of COPD, a disease traditionally marked by limited therapeutic innovations and a rather standardized approach to treatment. The successful application of biologics like Dupixent in treating type 2 inflammation-driven COPD could pave the way for more targeted and effective management strategies, offering hope for better disease outcomes for patients struggling with this debilitating condition.
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