RegulatoryOfficial

CHMP backs Krka's generic ruxolitinib for myelofibrosis, polycythaemia vera and graft-versus-host disease

🇪🇺 EMA · Fri 13 Nov 2026

The EMA committee adopted a positive opinion on 12 November 2026 for Ruxolitinib Krka, a generic of Jakavi, now awaiting a European Commission decision.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 12 November 2026, recommending a marketing authorisation for Ruxolitinib Krka. The applicant is KRKA, d.d., Novo mesto. EMA published the opinion summary on 13 November.

Ruxolitinib Krka is a generic of Jakavi, which has been authorised in the EU since 23 August 2012. According to EMA, studies showed the product to be of satisfactory quality and bioequivalent to the reference medicine. It will be available as 5 mg, 10 mg, 15 mg and 20 mg tablets.

The proposed indications cover disease-related splenomegaly or symptoms in adults with primary, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis, and adults with polycythaemia vera who are resistant to or intolerant of hydroxyurea. They also include acute graft-versus-host disease in patients aged 28 days and older, and chronic graft-versus-host disease in patients aged 6 months and older, in both cases after an inadequate response to corticosteroids or other systemic therapies.

Ruxolitinib is a protein kinase inhibitor (ATC code L01EJ01) that selectively inhibits Janus-associated kinases. EMA states that treatment should be started only by a physician experienced in using anticancer medicines. The detailed recommendations will appear in the summary of product characteristics, to be published in all official EU languages once the European Commission has granted the authorisation. The source indicates no new safety issue.

What it means for your team

  • Market-access teams should note that a CHMP opinion is not yet an authorisation; the European Commission decision is the next step before launch planning can be firm.
  • Regulatory affairs teams holding or tracking Jakavi should expect the generic's indications to mirror the reference product's full range, including both acute and chronic GvHD.
  • Labelling and product-information teams can expect the SmPC to be published in all EU languages after the Commission grants the authorisation.
  • Pharmacovigilance teams have no new safety signal to act on from this opinion, as none is indicated in the source.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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