Calliditas Therapeutics Pioneered Novel Endpoint for IgAN Drug Approval
- Calliditas Therapeutics utilized a novel renal primary surrogate endpoint, proteinuria reduction, in a Phase III trial for IgA nephropathy (IgAN).
- This approach enabled accelerated FDA approval for Calliditas's nephrology drug, a first in the field, setting a new precedent for rare renal disease treatments.
- CEO Renee Aguiar-Lucander emphasized the importance of this novel endpoint in overcoming the challenges of traditional endpoints like kidney failure in rare diseases.
- Calliditas has expanded globally, growing into a fully integrated biopharma company with a strong commercial presence in the U.S. and partnerships in key markets.
