Calliditas Therapeutics bags TARPEYO FDA approval for IgAN

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Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) has announced a landmark for () delayed release capsules, aimed at reducing kidney function loss in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Initially granted accelerated approval in December 2021, TARPEYO now stands as the first fully FDA-approved treatment for IgAN, based on kidney function measures.

TARPEYO: A Novel Approach to IgAN

TARPEYO, originally known as , is the only FDA-approved treatment for IgAN that significantly reduces kidney function loss. The approval comes with statistically significant evidence over placebo (p<0.0001) in estimated glomerular filtration rate (eGFR) over a two-year study period. This period included nine months of treatment with TARPEYO plus optimized renin-angiotensin system inhibitor (RASi) therapy and 15 months of follow-up.

Calliditas Therapeutics secures TARPEYO FDA approval for IgAN treatment

Calliditas Therapeutics secures TARPEYO FDA approval for IgAN treatment

At the two-year mark, the TARPEYO group showed a 50% less deterioration of kidney function compared to placebo-treated patients, marking a significant advancement in the treatment of this rare disease.

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TARPEYO’s Efficacy and Design

TARPEYO acts as a B-cell immunomodulator, targeting the source of IgAN and reducing the production of pathogenic galactose-deficient IgA1 antibodies. The reduction in proteinuria achieved with TARPEYO plus RASi at nine months was maintained throughout the 15-month off-drug period. This approval by the FDA caters to adults with primary IgAN, irrespective of proteinuria levels.

Phase 3 Clinical Trial Insights

The approval is based on data from the company’s Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study assessing the efficacy and safety of TARPEYO. The trial’s results underscore the drug’s potential as a disease-modifying agent in IgAN, according to Richard Lafayette, MD, FACP, of Stanford Healthcare.

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TARPEYO’s Accessibility and Patient Support

TARPEYO is available exclusively through Calliditas’ specialty pharmacy, Biologics by McKesson. To access TARPEYO, prescribers must fill out a TARPEYO Touchpoints Enrollment Form, which includes benefits like financial aid programs, care navigator assistance, and at-home delivery. Remarkably, 97% of patients taking TARPEYO have paid less than $10 per prescription, with 88% paying nothing at all, thanks to TARPEYO Touchpoints.

A Beacon of Hope for the IgAN Community

This first-ever full FDA approval for IgAN treatment based on kidney function is celebrated by the IgAN Foundation. Bonnie Schneider, director and cofounder, sees it as a beacon of hope and a critical step forward in the battle against IgAN.

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Conclusion: A New Era in IgAN Treatment

Calliditas Therapeutics’ TARPEYO, now fully FDA-approved, represents a breakthrough in the treatment of IgAN. This approval not only offers new hope to patients but also signifies a major step in the journey towards effective management and potential cure of this challenging rare disease.


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