Calliditas Therapeutics’ Tarpeyo Receives Full US FDA’s Approval for IgA Nephropathy to Reduce the Loss of Kidney Function
Shots:
- Followed by the accelerated approval in Dec 2021, the US FDA has now granted full approval to the company’s Tarpeyo for the treatment of IgA nephropathy (IgAN) based on a measure of kidney function
- The approval was supported by the results from the P-III (NefIgArd) study to investigate the efficacy and safety of Tarpeyo (16mg, QD) vs PBO for the treatment of patients (n=364) with primary IgAN as an optimized RASi therapy
- The impact of Tarpeyo on eGFR was evident by 3mos. and remained consistent over 2yrs., with a 5.9 mL/min/1.73 m2 difference in mean change from baseline vs PBO at the end of year 2. The observed effect on kidney function during the 9mos. treatment period persisted beyond treatment completion throughout the study
Ref: Calliditas | Image: Calliditas
Related News:- Calliditas Therapeutics Reports sNDA Submission to the US FDA for Tarpeyo to Treat Primary IgA Nephropathy
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
