Jakavi/Jakafi first post-steroid treatment for acute and chronic GvHD to win EC nod

9 May 2022

Swiss pharma giant Novartis (NOVN: VX) announced that the European Commission (EC) has approved Jakavi (ruxolitinib) in acute or chronic graft-versus-host disease (GvHD) who have inadequate response to corticosteroids or other systemic therapies.

The approval of Jakavi, which is marketed in the USA by Incyte Corporation (Nasdaq: INCY) as Jakafi, follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

"The approval of Jakavi offers healthcare providers and patients with GvHD who remain dependent on or refractory to steroids a new way to manage this debilitating and life-threatening condition"This recommendation was based on the Phase III REACH2 and REACH3 trials in which Jakavi demonstrated superiority in overall response rate compared to best available therapy.

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