Overview
- The MHRA granted marketing authorisation for depemokimab and said it will keep safety and effectiveness under close review.
- The injection, branded Exdensur, is an ultra-long-acting biologic administered subcutaneously once every six months.
- A Phase III study of 762 patients reported a 54% drop in clinically significant exacerbations and a 72% reduction in hospital admissions.
- Clinicians warn access will hinge on GSK’s pricing and NICE eligibility thresholds, with about 58,000 adults in England eligible for biologics but only around 21,000 receiving them.
- GSK says additional regulatory decisions are expected in the US, Japan, the EU and China.