Calliditas partner STADA receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy

"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. "This is an important event for patients suffering from IgAN inEuropeas Kinpeygo represents the...

"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.       

CONTACT:

For further information, please contact:

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Tel.: +46 76 403 35 43, Email: [email protected]

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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