Novartis receives CHMP backing for myelofibrosis drug

Novartis has been granted a recommendation for European regulatory approval of its drug Jakavi for the treatment of disease-related splenomegaly or symptoms in myelofibrosis patients.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the compound for use against the life-threatening blood cancer based on positive safety and efficacy data from the recent Comfort trials.

Jakavi is specified for adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis and would become the first EU-approved JAK inhibitor for this deadly disease.

It has already been granted orphan drug designation by the European Commission, which is likely to come to its final approval decision within the next three months.

Herve Hoppenot, president at Novartis Oncology, said: "Novartis is committed to advancing novel targeted treatments for rare diseases, and we are invested in continuing research to determine other haematological diseases where Jakavi may address unmet patient needs."

Earlier this month, the company reported positive clinical data from three studies of QVA149, a promising treatment for chronic obstructive pulmonary disease.