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CTI Pharma and Baxalta complete rolling submission to FDA for pacritinib as a treatment for myelofibrosis

Read time: 1 mins
Last updated: 13th Jan 2016
Published: 13th Jan 2016
Source: Pharmawand

CTI BioPharma and Baxalta announced the completion of the rolling submission of the US NDA for the JAK inhibitor pacritinib, for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of <50,000/µL – a specific patient population for which there is an existing unmet medical need. The companies are seeking accelerated approval and have requested a Priority Review of the application.

Comment: Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anaemia than has been seen in currently approved and in-development JAK inhibitors.

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