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.
- 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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