The approval was based on the efficacy & safety data of Part A of an ongoing P-III (NeflgArd) study to evaluate Kinpeygo (16mg, qd) vs PBO in adult patients with primary IgAN who are at risk of rapid disease progression with UPCR ≥1.5 g/gram
The results showed a 31% vs 5% reduction in proteinuria from baseline @9mos. of treatment, 7% treatment benefit on eGFR corresponded to a slight decrease from baseline of 0.17 mL/min/1.73 m2 in patients who received Kinpeygo and deterioration from baseline of 4.04 mL/min/1.73m2 in patients with PBO
The marketing authorization will be valid in all 27 EU member states, Iceland, Norway & Liechtenstein. Calliditas commercial partner STADA plans to launch Kinpeygo in the EEA in H2’22
Ref: PRNewswire | Image: Calliditas Therapeutics
