Novartis’s myelofibrosis drug Jakavi receives EU approval

Novartis has been granted European regulatory approval for Jakavi, a new therapy for the life-threatening blood cancer myelofibrosis.

The innovative JAK 1 and JAK 2 inhibitor has been approved by the European Commission for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

It is the first therapy for this disease to be approved in Europe, having demonstrated its safety and efficacy in the pivotal phase III clinical trials known as Comfort-I and Comfort-II.

Jakavi was shown to be able to reduce spleen size and debilitating disease manifestations by targeting the underlying mechanism of myelofibrosis, a condition associated with progressive symptoms and a reduced quality of life.

Herve Hoppenot, president of Novartis Oncology, said: "We are committed to the development of innovative treatments for orphan diseases and are furthering research to assess the potential of targeted Jakavi therapy for other malignancies associated with a dysregulated JAK pathway."

This comes after the firm recently received European approval for its drug Afinitor to be used to treat the most common form of breast cancer.