Depemokimab FDA Approval Status
Last updated by Judith Stewart, BPharm on March 3, 2025.
FDA Approved: No
Generic name: depemokimab
Company: GlaxoSmithKline
Treatment for: Asthma, Chronic Rhinosinusitis With Nasal Polyps
Depemokimab is a long-acting interleukin-5 antagonist in development for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps.
- Asthma is a common respiratory condition characterized by variable symptoms of breathlessness, cough, chest tightness, and wheeze. Type 2 inflammation occurs after exposure to allergens, which cause a systemic allergic response that involves the activation of immune cells (eosinophils, mast cells and T-cells) which release inflammatory mediators (cytokines, chemokines and IgE antibodies), resulting in airway inflammation, and an increased risk of asthma exacerbations and decreased lung function.
- Chronic rhinosinusitis with nasal polyps (CRSwNP) is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps. Symptoms include nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge.
- Depemokimab is an ultra-long-acting biologic that works by suppressing interleukin-5 (IL-5), a key cytokine and known driver of type 2 inflammation.
- Depemokimab has an extended half-life, and a high-binding affinity and potency that enables a six month (26 week) dosing regimen.
- A Biologics License Application (BLA) has been accepted for review by the U.S. Food and Drug Administration (FDA) for depemokimab for use in two indications:
- add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller, and as
- add-on maintenance treatment in adult patients with inadequately controlled CRSwNP. - Submission of the BLA was based on data from the SWIFT and ANCHOR trials:
- SWIFT-1 and -2 showed depemokimab reduced exacerbation and hospitalisation rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo, and
- ANCHOR-1 and -2 showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo. - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 16, 2025.
Development timeline for depemokimab
Further information
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