GSK Advancing Ultra-Long-Acting Therapies in Respiratory and HIV Care

The European Commission's has approved depemokimab (brand name, Exdensur) for the treatment of severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.¹ The approval represents the first ultra-long-acting biologic approved in the European Union (EU) for respiratory diseases. This milestone was achieved through high binding affinity and an extended half-life that enables a twice-yearly dosing schedule. Kaivan Khavandi SVP, global head, Respiratory, Immunology & Inflammation R&D, GSK, stated in a press release,¹ “The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. Exdensur may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year.”

How Are Ultra-Long-Acting Formulations Reshaping Respiratory and Chronic Disease Management?

The technical challenge of sustaining suppression of disease-driving inflammation with only two doses per year requires advanced engineering to ensure high potency against interleukin-5.¹ This innovation addresses significant unmet needs in the approximately 3 million people in the EU living with severe asthma. Stephanie Korn MD, PhD, head of the Clinical Research Centre IKF Pneumologie Mainz said in the press release,¹ “People living with the burden of severe asthma face persistent exacerbations driven by uncontrolled type 2 inflammation. A new option with twice-yearly dosing that could provide sustained suppression of type 2 inflammation is a promising innovation for patients in Europe with severe asthma who are in urgent need of novel solutions.” Additionally, Eugenio De Corso MD, PhD, professor at University of Perugia, emphasized the impact on quality of life for those with chronic rhinosinusitis with nasal polyps, noting¹ “CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction which can make breathing, smell, sleeping and other fundamental activities a major challenge. An innovative treatment option like Exdensur, that could help patients achieve their treatment goals in fewer doses, represents an important advance.”

What Role Do Real-World Evidence and Complex Formulation Play in Enhancing Therapeutic Outcomes?

The focus on long-term protection extends to preventive medicine and infectious disease, where real-world evidence is clarifying the broader systemic benefits of vaccination.² New data for the recombinant respiratory syncytial virus (RSV) vaccine, which utilizes a proprietary adjuvant system, indicate 75.6% effectiveness against related hospitalizations in older adults. This evidence suggests that preventing respiratory syncytial virus can also reduce risks of major adverse cardiovascular events and flare-ups of chronic obstructive pulmonary disease (COPD). Deepak L. Bhatt MD, MPH, MBA, director of Mount Sinai Fuster Heart Hospital, stated in a press release,² “In the real-world data being presented at RSVVW’26, it is observed that RSV vaccination could help reduce the risk of certain serious RSV-related outcomes, potentially including major adverse cardiovascular events such as heart attack and stroke, as well as severe flare-ups of COPD and asthma. These new data are a significant step in our understanding of how to help prevent such RSV-related health outcomes. I look forward to more data investigating this association further.” Christian Felter, GSK Global Medical Lead, RSV, added,² “These data underscore the value of our RSV vaccine in its observed association with helping to prevent RSV-related hospitalisation and reducing the risk of acute events of certain chronic conditions associated with this potentially serious disease. We are proud of our contribution at the forefront of generating innovative research in RSV to inform the clinical community and improve outcomes for patients.”

Concurrently, the development of ultra-long-acting candidates in HIV treatment represents a significant move toward dosing intervals of four months or more.³ Pipeline assets, which include capsid inhibitors and third-generation integrase inhibitors, are being evaluated for their ability to maintain viral suppression with fewer interventions. Regarding these advancements, Jean van Wyk MBChB, MFPM, chief medical officer at ViiV Healthcare, said in a press release,³ “We are making major advances towards new ultra long‑acting regimens that build on ViiV’s legacy of integrase inhibitors, including pipeline assets such as VH184 that have the potential to extend dosing intervals to four months or longer – beyond what is available today for HIV treatment. Listening to the needs of the HIV community shapes our research and development, and the breadth of clinical and real‑world data we are presenting at CROI 2026 reflects our commitment to delivering long‑acting therapies that people impacted by HIV need and want.”

References

1. GSK. Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps. GSK Press Release. 2026. Available at: https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-the-european-commission/. Accessed February 17, 2026
2. GSK. GSK’s Arexvy associated with reductions in certain RSV-related risks, including heart attack, stroke and severe flare-ups of COPD and asthma, real-world study shows. Press release. 2026. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-s-arexvy-associated-with-reductions-in-certain-rsv-related-risks-including-heart-attack-stroke-and-severe-flare-ups-of-copd-and-asthma-real-world-study-shows/. Accessed February 17, 2026.
3. GSK. ViiV Healthcare showcases long-acting HIV innovation and potential of ultra long-acting pipeline, including new data for first third-generation integrase inhibitor at CROI 2026. GSK Press Release. 2026. Available at: https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-showcases-long-acting-hiv-innovation-and-potential-of-ultra-long-acting-pipeline-at-croi-2026/. Accessed February 17, 2026.