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

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

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post