CALT Calliditas Therapeutics AB

STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).

The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours. This expanded label is based on full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet ^(1).

"This is an important event for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this rare kidney disease.  The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are delighted that the European Commission has granted a full approval for the broader population" said Renee Aguiar-Lucander, CEO.

Kinpeygo is marketed in in the EU and UK exclusively by Calliditas' commercial partner, STADA Arzneimittel AG.

The full marketing authorization for Kinpeygo covers the European Union (EU) member states as well as Iceland, Norway and Liechtenstein. Also, Kinpeygo's status as an orphan drug for a rare disease, subject to 10-year market exclusivity running until 2032, was confirmed by the Commission.

This approval triggers a milestone payment of ten million EUR to Calliditas, which will be recognized as revenue in the third quarter.       

1. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial - The Lancet

CONTACT:

For further information, please contact:

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com

The information was sent for publication, through the agency of the contact person set out above, on July 26, 2024 at 5:00 p.m. CET.

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SOURCE Calliditas Therapeutics