Kinpeygo® for IgA nephropathy gets positive CHMP opinion for full approval

STOCKHOLM, May 30, 2024 – Calliditas Therapeutics AB, a biopharmaceutical company listed on both Nasdaq (CALT) and Nasdaq Stockholm (CALTX), has announced a significant milestone. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending full marketing authorisation for Kinpeygo, a treatment for adults with primary immunoglobulin A nephropathy (IgAN).

Kinpeygo initially received conditional marketing authorisation in the EU on July 15, 2022, marking it as the first approved treatment for IgAN in both the EU and the UK. The recent positive opinion by the CHMP aims to broaden the medication's label, expanding from an initial urine protein excretion (UPCR) limitation of greater than 1.5g/g to a new threshold that includes the entire study population with a UPCR of 0.8g/g or proteinuria of 1.0g/g over 24 hours. Kinpeygo is marketed exclusively in the EU and UK by Calliditas' commercial partner, STADA Arzneimittel AG.

Renee Aguiar-Lucander, CEO of Calliditas, expressed the importance of this development, stating, "This is an important day for patients suffering from IgAN in Europe. Kinpeygo represents the first 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 EMA has now issued a positive opinion."

Following the CHMP's positive opinion, the decision will be forwarded to the European Commission (EC). The EC has the authority to grant full marketing authorisation applicable across EU member states, as well as Iceland, Norway, and Liechtenstein. A final decision from the EC is anticipated by August 2024.

Calliditas Therapeutics, headquartered in Stockholm, Sweden, focuses on identifying, developing, and commercializing novel treatments for orphan diseases with significant unmet medical needs. The company's common shares are listed on Nasdaq Stockholm (CALT) and its American Depositary Shares on the Nasdaq Global Select Market (CALT).

About Calliditas Therapeutics
Calliditas Therapeutics AB is a biopharmaceutical company dedicated to developing treatments for rare diseases with high unmet medical needs. The company’s shares are traded on Nasdaq Stockholm and the Nasdaq Global Select Market.

The positive opinion from the CHMP is a critical step forward for Calliditas, investors, and most importantly, patients suffering from IgAN across Europe. This development signifies a promising future for effective treatment options for this rare kidney disease.

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