Regeneron Pharmaceuticals and Sanofi announced that their Dupixent (dupilumab) has been approved in the US and China to treat patients with chronic obstructive pulmonary disease (COPD).
Dupixent is a monoclonal antibody that targets interleukin 4 and interleukin 13, used for allergic diseases such as atopic dermatitis, asthma and nasal polyps which result in chronic sinusitis.
The US Food and Drug Administration (FDA) has approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
China’s National Medical Products Administration (NMPA) approved the drug as an add-on maintenance treatment for adults with uncontrolled COPD with raised blood eosinophils.
The approval covers patients already taking a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or a combination of LABA and LAMA if ICS is not appropriate.
Sanofi and Regeneron are jointly developing Dupilumab under a worldwide collaboration.
According to the companies, Dupixent has been approved for the treatment of COPD in more than 30 countries worldwide, including the 27 countries in the EU.
Sanofi CEO Paul Hudson: “Dupixent has already shown it can revolutionize the treatment paradigm of many diseases driven in part by type 2 inflammation with high unmet medical needs, with one million patients being treated globally across all currently approved indications.
“With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD.”
Both FDA and NMPA approvals are based on data from two Phase 3 trials, BOREAS and NOTUS, which evaluated the efficacy and safety of Dupixent compared to placebo.
In the two studies, patients who received Dupixent experienced 30% and 34% reduction in moderate or severe COPD exacerbations over 52 weeks, which is the primary endpoint.
The patients also experienced improvements in post-bronchodilator FEV1 and response in health-related quality of life measures in both trials compared to placebo.
The BOREAS and NOTUS studies showed safety results that were generally consistent with the known safety profile of Dupixent in its approved indications.
Regeneron board co-chair, president and chief scientific officer and Dupixent study principal inventor George Yancopoulos said: “This latest approval represents an important next chapter for Dupixent, giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations.”
Sanofi research and development head and executive vice president Houman Ashrafian said: “China has the largest number of people living with COPD worldwide, and a significant proportion of patients are uncontrolled on current therapies and desperate for an effective treatment option.
“The Dupixent COPD clinical program has furthered our scientific understanding of COPD and given us a new way to think about which patients could benefit most from such a treatment.”
In July this year, the European Medicines Agency (EMA) approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD with increased blood eosinophils.
