Logo

Calliditas’ Kinpeygo Receive EC's Marketing Authorization for the Treatment of Primary Immunoglobulin A Nephropathy

Share this

Calliditas’ Kinpeygo Receive EC's Marketing Authorization for the Treatment of Primary Immunoglobulin A Nephropathy

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions