STADA Gets European Marketing Authorization For Kinpeygo

STADA Gets European Marketing Authorization For Kinpeygo

By, Admin 30 July 2024

Calliditas partner STADA gets European marketing authorization for Kinpeygo to treat primary immunoglobulin A nephropathy

Overview

Calliditas Therapeutics AB (Calliditas) announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).

Marketing Authorization Grant

  • 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.

Words from the CEO

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 in EU

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

Authorization Coverage

  • 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.
  • Post approval- 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.

About Calliditas Therapeutics

Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs.

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