GSK has received US market approval for Exdensur (depemokimab) for the treatment of severe asthma. The therapy is a next-generation anti-IL-5 monoclonal antibody (mAb) featuring an extended half-life, high binding affinity and potency, enabling administration just once every six months. This contrasts with GSK's first-generation IL-5 inhibitor, mepolizumab, which is administered monthly and generated approximately USD 2.2 billion in global sales in 2024.
The registration approval is based on positive results from two Phase III trials, SWIFT-1 and SWIFT-2, which demonstrated that depemokimab significantly reduced the rate of asthma exacerbations over 52 weeks compared to a placebo. In a separate regulatory decision, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved depemokimab on 15 December 2025 for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
PharmCube's NextBiopharm® database shows that depemokimab is the third anti-IL-5 mAb to reach the global market, while two other contenders are currently in Phase III. Click here to request a free trial for NextBiopharm®.
