Novartis has received approval from the European Commission (EC) for its oral therapy Jakavi (ruxolitinib) to treat patients aged 12 years and above with acute or chronic graft-versus-host disease (GvHD).
These patients have inadequate response to corticosteroids or other systemic therapies.
Jakavi, an oral JAK 1 and JAK 2 tyrosine kinases inhibitor, was licensed by Novartis from Incyte to develop and commercialise outside the US.
Novartis Innovative Medicines International president and chief commercial officer Marie-France Tschudin said: “Five out of ten patients who receive allogeneic stem cell transplants experience the serious and sometimes fatal symptoms of graft-versus-host disease.
“Jakavi, with this new indication in GvHD, will help to redefine treatment for patients who do not respond to first-line care.”
Prior to this approval, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted positive opinion for Jakavi in March this year.
The CHMP approval was based on the Phase III REACH2 and REACH3 trials in which the therapy demonstrated overall response rate (ORR) superiority as against best available therapy (BAT).
GvHD symptoms can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs and joints.
Jakavi secured approval in more than 100 countries for patients with MF, including EU countries, Canada, Switzerland and Japan. It is also approved in over 85 countries for patients with PV.
Regulatory filings globally are also underway in MF and PV.
Incyte markets ruxolitinib in the US as Jakafi for adults with PV who have had an inadequate response to or are intolerant of hydroxyurea.
It is also intended for use by adults with intermediate or high-risk MF, for adult and pediatric patients aged 12 years and above with steroid-refractory acute GvHD and chronic GvHD.