Overview
- The CHMP recommended a conditional marketing authorisation for adults and for children aged 12 and older who weigh at least 40 kg when other treatments offer limited benefit, are unsuitable, or have been exhausted.
- The recommendation is based on an open-label study in patients whose disease was not controlled with corticosteroids and at least two prior systemic therapies.
- Across six months, 73% of patients responded to once-daily Rezurock, including about 5% complete responses and roughly 68% partial responses, with 44% maintaining a response at six months.
- As a condition of the pathway, the company has committed to a confirmatory randomised controlled trial to verify efficacy.
- Rezurock is an oral ROCK2 inhibitor taken once daily with food; commonly reported side effects include fatigue, diarrhoea, nausea, headache, vomiting and elevated liver enzymes, and EU-wide access will depend on the Commission’s decision followed by national pricing and reimbursement.