Trade Resources Industry Views Novartis Received The European Commission Approval for Jakavi

Novartis Received The European Commission Approval for Jakavi

Novartis, Incyte's strategic collaborator, has received the European Commission approval for Jakavi (INC424, ruxolitinib), an oral JAK 1 and JAK 2 inhibitor to treat patients with myelofibrosis.

The oral JAK 1 and JAK 2 inhibitor discovered by Incyte is indicated for the treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis in the Europe.

According to a worldwide collaboration and license agreement signed between Incyte and Novartis in 2009, Novartis gained rights for the development and potential commercialization of ruxolitinib in all hematology-oncology indications outside of the US.

Incyte kept hold of the development and commercialization rights of ruxolitinib in the US, won FDA approval for ruxolitinib and marketed it under the brand name Jakafi in the US.

Jakafi (ruxolitinib) is indicated for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in the US.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/european-commission-approves-novartis-myelofibrosis-therapy-290812
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European Commission Approves Novartis Myelofibrosis Therapy