Calliditas Receives CHMP Positive Opinion of Kinpeygo for the Treatment of Primary Immunoglobulin A Nephropathy
Shots:
- The EMA has adopted a positive opinion recommending conditional marketing authorization for Kinpeygo in patients with primary IgAN who are at risk of rapid disease progression with a UPCR ≥1.5g/gram
- The results from part A of the P-III (NeflgArd) study showed that patients treated with Kinpeygo (16mg, qd) achieved a 31% reduction in proteinuria from baseline over 5% in PBO @9mos.
- Kinpeygo will receive marketing authorization in all EU member states, Iceland, Liechtenstein & Norway with an expected EC decision in Q3’22. If approved by EC, Kinpeygo will be the 1st approved therapy for IgAN while STADA Arzneimittel AG will be the sole distributor of Nefecon, developed under the brand name Nefecon
Ref: PR Newswire | Image: Calliditas
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