MHRA Approves Dupixent for Uncontrolled COPD

Sanofi and Regeneron’s medication Dupixent (dupilumab) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for use as an additional maintenance treatment for chronic obstructive pulmonary disease (COPD) in the UK. This approval targets adults with uncontrolled COPD who exhibit elevated blood eosinophils, marking Dupixent as the first targeted biologic for this condition in the country.

Candidates for Dupixent therapy will already be undergoing treatment with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or a LABA/LAMA combination in cases where ICS is unsuitable. The approval from MHRA follows a similar authorization by the European Medicines Agency (EMA) for the same use, which occurred just two months prior. The approval is backed by promising data from the BOREAS and NOTUS clinical trials, which involved adults with uncontrolled COPD and signs of type 2 inflammation. In these trials, all participants were receiving maximal standard-of-care inhaled therapies, predominantly triple therapy.

In the BOREAS and NOTUS trials, Dupixent showed a significant reduction in annualized moderate or severe COPD exacerbations by 30% and 34%, respectively, compared to a placebo over the course of one year. Additionally, patients treated with Dupixent exhibited lung function improvements as early as two to four weeks into treatment, sustained throughout the year. The treatment also enhanced health-related quality of life, measured by the St George’s Respiratory Questionnaire.

In the UK, approximately 1.4 million people suffer from COPD, a chronic respiratory disease that leads to progressive lung function decline and symptoms such as persistent coughing, excessive mucus, and shortness of breath. Dupixent, already approved for various other conditions, is a fully human monoclonal antibody that inhibits the interleukin-4 and interleukin-13 pathways. These pathways are significant drivers of type 2 inflammation, which is a key factor in numerous related diseases, including COPD.

Rippon Ubhi, Sanofi UK and Ireland’s country lead, stated that this new approval of Dupixent signifies a major change in the treatment landscape for COPD patients. She emphasized the clinical evidence showing that Dupixent reduces COPD exacerbations and enhances lung function, highlighting the importance of working with regulatory bodies to facilitate patient access to this treatment in the UK.

Henry Gregg, director of external affairs at Asthma + Lung UK, also shared his thoughts on the approval. He noted the lack of recent advancements in COPD treatments and expressed optimism that Dupixent’s approval by the MHRA represents a significant development for individuals with uncontrolled COPD. With EMA’s prior approval, Gregg welcomed the UK’s decision to follow suit, seeing it as a potential game-changer for COPD patients’ lives. He mentioned that it is now up to the National Institute for Health and Care Excellence to decide if Dupixent will be recommended for NHS use.