Celgene’s Fedratinib Receives FDA’s Priority Review to NDA Filing for Myelofibrosis

Shots:

• Celgene announces the acceptance of Fedratinib’s NDA based on P-III JAKARTA study assessing Fedratinib (400mg/500mg) vs PBO in 289 patients with primary or secondary myelofibrosis across 24 countries
• The P-III JAKARTA study results: meeting its 1EPs & 2EPs i.e, reduction in spleen volume (35%) & reduction in Total Symptom Score (50%) after six one-month treatment cycles
• Fedratinib (400mg/500mg) is JAK2 & FLT3 inhibitor, activates transcription proteins (STAT3/5), and induced apoptotis. Fedratinib has received FDA’s PR & OD designation for primary/secondary myelofibrosis with its expected PDUFA date on 3 Sept, 2019

Click here to read full press release/ article | Ref: Celgene | Image: Investor’s Business Daily