Novartis Submits New Indication Application for JAK Inhibitor Ruxolitinib Tablets in China

On May 27, the CDE website showed that Novartis' JAK inhibitor Ruxolitinib Tablets (ruxolitinib) new indication marketing application was accepted by the National Medical Products Administration.

Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor.Ruxolitinib tablets were first approved for marketing by the National Medical Products Administration (NMPA) through a priority review process in March 2017. They are indicated for the treatment of adult patients with intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), to treat disease-related splenomegaly or disease-related symptoms.Novartis is responsible for the commercialization of its tablets outside the United States under the trade name Jakavi, while Incyte is responsible for the development and commercialization of ruxolitinib in the United States under the trade name Jakafi.