The landscape of respiratory medicine saw significant developments on December 23, 2025, as two major pharmaceutical advancements came to light on opposite sides of the globe. In the United States, GSK plc announced a landmark agreement with the federal government to lower prescription medicine costs for millions of Americans, particularly those suffering from asthma and chronic obstructive pulmonary disease (COPD). Meanwhile, in Japan, Regeneron Pharmaceuticals and Sanofi revealed that their biologic therapy Dupixent (dupilumab) received regulatory approval for use in children aged 6 to 11 with severe bronchial asthma, marking a pivotal moment for pediatric respiratory care.
According to Investing.com, GSK’s agreement with the U.S. government is poised to impact over 40 million Americans who rely on its respiratory treatments. This move comes in response to four actions requested by President Trump in a letter dated July 31, 2025. The company will reduce prices for certain medicines within Medicaid and implement a new pricing strategy for upcoming products, one that weighs the value of innovation across developed countries. Notably, GSK will also launch a direct purchasing platform, making the majority of its inhaled respiratory products and other medicines available at savings of up to 66%.
GSK’s commitment doesn’t stop at pricing. The agreement includes support for the U.S. Strategic Active Pharmaceutical Ingredients Reserve—a measure aimed at boosting the nation’s resilience in the supply of critical medicines. Specifically, GSK has pledged to secure a reserve of albuterol (also known as salbutamol), a key ingredient in inhalers for both asthma and COPD. This step is designed to shore up the U.S. supply chain, a concern that’s only grown in prominence in recent years.
The deal extends to both GSK and its affiliate ViiV Healthcare, and, crucially, exempts both companies from Section 232 tariffs for a period of three years. While the specific terms remain confidential, the agreement provides much-needed clarity on future pricing frameworks in the United States—a landscape that’s often fraught with uncertainty for both patients and pharmaceutical companies.
GSK CEO Emma Walmsley emphasized the significance of the agreement, stating, “This agreement will ensure patients have access to the current portfolio of respiratory medicines while bringing the next wave of innovation to American patients.” Her remarks, as reported by Investing.com, underscore the company’s dual focus on immediate affordability and long-term advancement in respiratory care.
This announcement follows GSK’s September 2025 declaration of its intent to invest more than $30 billion in U.S. research, development, and manufacturing over the next five years. Of that, $2 billion is earmarked for manufacturing, artificial intelligence, and digital technologies—areas that are rapidly transforming the pharmaceutical industry. GSK’s U.S. workforce currently stands at approximately 15,000 employees, reflecting the company’s longstanding commitment to the American market.
While GSK’s news reverberated through the U.S. healthcare sector, Regeneron Pharmaceuticals and Sanofi made headlines in Japan with a breakthrough for pediatric asthma patients. As detailed in a joint press release, Japan’s Ministry of Health, Labour and Welfare granted marketing and manufacturing authorization for Dupixent (dupilumab) for children aged 6 to 11 years suffering from severe or refractory bronchial asthma that is inadequately controlled by existing therapies. This approval expands the drug’s previous indication, which covered patients aged 12 and older.
The decision is grounded in robust clinical evidence. Data from the global Phase 3 VOYAGE trial and the EXCURSION open-label extension study—including a sub-study focusing on Japanese pediatric patients—demonstrated that Dupixent, when added to standard-of-care asthma therapy, significantly reduced severe exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo. These results are particularly notable as Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized Phase 3 trial.
Dupixent’s mechanism of action is unique: it inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are central drivers of type 2 inflammation—a key factor in asthma and several related diseases. Unlike traditional immunosuppressants, Dupixent is a fully human monoclonal antibody developed using Regeneron’s proprietary VelocImmune technology, which leverages genetically engineered mice with humanized immune systems to produce optimized antibodies.
With its approval in Japan, Dupixent is now available as a 200 mg or 300 mg pre-filled syringe or pen, administered subcutaneously every two or four weeks depending on the child’s weight. The therapy can be given in a clinical setting or at home by a caregiver, following proper training by a healthcare professional. This flexibility is a boon for families managing chronic conditions in children, allowing for more convenient and consistent care.
Asthma remains one of the most common chronic diseases in children, and despite advances in inhaled corticosteroids and bronchodilators, many young patients continue to experience debilitating symptoms. These can include coughing, wheezing, and difficulty breathing—symptoms that not only disrupt daily life but can also impede lung development and lead to persistent airway obstruction if not addressed early. The availability of a biologic therapy like Dupixent, which targets the underlying inflammation rather than just the symptoms, could mark a new era in pediatric asthma management.
Globally, Dupixent is approved in over 60 countries for various indications, including asthma in children aged 6 to 11 years. More than 1.3 million patients are currently being treated with the drug, a testament to its growing acceptance and clinical value. Beyond asthma, Dupixent holds approvals for conditions such as atopic dermatitis, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and COPD, among others.
The approval in Japan is not just a win for Regeneron and Sanofi but also a significant step forward for pediatric patients and their families, who often struggle to find effective, long-term solutions for severe asthma. The companies continue to explore additional indications for Dupixent, with ongoing Phase 3 trials targeting a range of diseases driven by type 2 inflammation or other allergic processes.
As the pharmaceutical industry closes out 2025, these twin announcements from GSK and the Regeneron-Sanofi partnership illustrate how innovation, regulatory collaboration, and a focus on patient access are reshaping the landscape of respiratory care. Whether through bold investments in research and manufacturing or the introduction of groundbreaking therapies for previously underserved populations, the momentum in respiratory medicine shows no sign of slowing.
