- NMPA approved Exdensur (depemokimab) in China as add-on to intranasal corticosteroids for adults with CRSwNP uncontrolled by systemic corticosteroids and/or surgery.
- ANCHOR‑1/2 phase III trials (total n=528) showed nasal polyp score reductions at 52 weeks: ANCHOR‑1 −0.7 (95% CI −1.1, −0.3; p<0.001) and ANCHOR‑2 −0.6 (95% CI −1.0, −0.2; p=0.004), with nasal obstruction VRS improvements at weeks 49–52 (ANCHOR‑1 −0.23, p=0.047; ANCHOR‑2 −0.25, p=0.025).
- Depemokimab is an IL‑5‑targeting, ultra‑long‑acting biologic formulated for twice‑yearly dosing (26‑week intervals).
- Ongoing phase III programmes include OCEAN (EGPA), DESTINY (HES), and ENDURA‑1/2 and VIGILANT in COPD with type‑2 inflammation.
Regulatory approval
China’s NMPA approved Exdensur (depemokimab) as an add‑on to intranasal corticosteroids for adults with CRSwNP inadequately controlled by systemic corticosteroids and/or surgery; Exdensur is also approved for severe asthma in the US and China and for severe asthma and CRSwNP in Japan, the EU and UK.
Clinical evidence
Approval was based on ANCHOR‑1 and ANCHOR‑2 phase III replicate trials (total n=528) that showed nasal polyp score reductions at 52 weeks (ANCHOR‑1 −0.7, 95% CI −1.1 to −0.3, p<0.001; ANCHOR‑2 −0.6, 95% CI −1.0 to −0.2, p=0.004) and improvements in nasal obstruction VRS over weeks 49–52 (ANCHOR‑1 −0.23, p=0.047; ANCHOR‑2 −0.25, p=0.025); safety and adverse‑event rates were similar to placebo plus standard of care.
Mechanism and dosing
Depemokimab is an IL‑5‑targeting, ultra‑long‑acting biologic designed for twice‑yearly (26‑week) dosing as add‑on therapy to maintenance intranasal corticosteroids.
Patient population and development
Trials enrolled adults with bilateral nasal polyps and inadequately controlled disease who had prior surgery, prior systemic corticosteroids or intolerance to systemic steroids; depemokimab is in additional phase III programmes for EGPA (OCEAN), hypereosinophilic syndrome (DESTINY) and COPD with type‑2 inflammation (ENDURA‑1/2, VIGILANT).
