Celgene’s Inrebic (fedratinib) Receives the US FDA’s Approval for Myelofibrosis

 Celgene’s Inrebic (fedratinib) Receives the US FDA’s Approval for Myelofibrosis

Celgene’s Inrebic (fedratinib) Receives the US FDA’s Approval for Myelofibrosis

Shots:

  • The approval is based on multiple studies including JAKARTA and JAKARTA2. The P-III JAKARTA study involves assessing of Inrebic (400mg) vs PBO in patients with intermediate-2 or high-risk, primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with splenomegaly and a platelet count of ≥50 x 109/L2 prior not treated with JAK inhibitor
  • The P-III JAKARTA study results: @24wks. with 4wks. follow up scan, >35% reduction in spleen volume (37% vs 1%); >50% improvement in TSS as measured by (MFSAF) v2.0 diary (40% vs 9%)
  • Inrebic is an oral kinase inhibitor targeting JAK2 & FLT3, new therapy in nearly a decade for patients affected by rare bone marrow cancer and is gained by Celgene with the acquisition of Impact Biomedicines for $7B

Click here to­ read full press release/ article | Ref: Celgene | Image: Flickr

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post