Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Jakavi to treat acute and chronic graft versus host disease
25 March 2022 - CHMP opinion based on Phase 3 REACH2 and REACH3 trials that showed Jakavi improved response rates and failure-free survival compared to best available therapy.
Novartis announced today the CHMP of the EMA has adopted a positive opinion recommending approval of Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease (GvHD) who have inadequate response to corticosteroids or other systemic therapies.
If approved, Jakavi will be the first JAK1/2 inhibitor available for patients with GvHD in Europe.
