Shots:

• The two P-III J01 & J03 studies involve assessing of Vadadustat vs darbepoetin alfa in 304 & 323 Japanese patients (non- dialysis dependent & dialysis dependent) with anemia due to CKD @52wks.
•   The P-III J01 & J03 studies result: met its 1EPs; @20 &24 wks. mean Hb level (11.66 g/dL & 10.61 g/dL vs 11.93 g/dL & 10.65 g/dL); SAEs (13.9% & 13.0% vs 14.4% & 10.6%)
• Vadadustat is an oral HIF prolyl hydroxylase inhibitor- co-developed by Akebia & MTPC with its expected NDA filing in Japan in 2019

Ref: Akebia | Image: Contract Pharma