Euro advisory group backs Bristol Myers' Inrebic in myelofibrosis
- The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Bristol Myers Squibb's (NYSE:BMY) Inrebic (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
- The European Commission will review the recommendation and final decision is expected within 67 days of receipt of the CHMP opinion.
- The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.
- https://seekingalpha.com/news/3643650-european-advisory-group-backs-bristol-myers-inrebic-in-myelofibrosis
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