Shots:

• The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory chronic GVHD. The findings were recently presented at the 62nd ASH Annual Meeting & Exposition
• The study showed greater ORR @24wks. i.e 1EPs (49.7% vs 25.6%); @24wks. mFFS (not reached vs 5.7 mos.); greater symptom improvement per mLSS (24.2% vs 1.0%); no new safety signals were observed while AEs were consistent
• The PR shortens the review period from 10 to 6mos. The anticipated PDUFA date is Jun 22- 2021

 ­ Ref: Businesswire | Image: The Business Journals