Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo® for the treatment of IgA nephropathy

Rhea-AI Summary

Calliditas Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Kinpeygo, recommending full marketing authorisation in treating adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which received conditional marketing authorisation in July 2022, now has a broader treatment label, moving from a urine protein excretion limitation of >1.5g/g to ≥0.8g/g. The positive opinion will be forwarded to the European Commission (EC) for final approval, expected in August 2024. STADA Arzneimittel AG will market Kinpeygo in the EU and UK.

Positive

• CHMP adopted a positive opinion for Kinpeygo, recommending full marketing authorisation.
• Broader treatment label for Kinpeygo, expanding from UPCR limitation of >1.5g/g to ≥0.8g/g.
• First fully approved medication for IgAN in Europe.
• Long-term confirmatory trial met its eGFR endpoint with high statistical significance.
• Kinpeygo will be marketed in the EU and UK by STADA.

Negative

• Final decision by the European Commission is still pending, expected in August 2024.

STOCKHOLM, May 30, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).

Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and UK. 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. Kinpeygo is marketed in in the EU and UK exclusively by Calliditas' commercial partner, STADA Arzneimittel AG.

"This is an important day 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 EMA now has issued a positive opinion," said Renee Aguiar-Lucander, CEO.

The CHMP's positive opinion will now be forwarded to the European Commission (EC), which has the authority to grant this full marketing authorisation for Kinpeygo in the European Union (EU) member states, and which will be adopted by Iceland, Norway and Liechtenstein. A final decision by the EC on granting a marketing authorisation is anticipated in August 2024.

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 in the report is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact person set out above, on May 30, 2024, at 8:00 p.m. CET.

About Calliditas

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. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com for further information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, EC authorization for full approval of Kinpeygo, continued and additional regulatory approvals for TARPEYO and Kinpeygo, market acceptance of TARPEYO and Kinpeygo, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, revenue and product sales projections or forecasts and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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EMA Positive Opinion PR_ENG

 

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SOURCE Calliditas Therapeutics

FAQ

What is the latest update on Kinpeygo for treating IgA nephropathy?

The CHMP has adopted a positive opinion recommending full marketing authorisation for Kinpeygo.

What change has been made to the Kinpeygo treatment label?

The treatment label for Kinpeygo has been broadened from a urine protein excretion limitation of >1.5g/g to ≥0.8g/g.

When is the final decision on Kinpeygo's marketing authorisation expected?

The final decision by the European Commission is anticipated in August 2024.

Who will market Kinpeygo in the EU and UK?

STADA Arzneimittel AG will market Kinpeygo in the EU and UK.

When was Kinpeygo granted conditional marketing authorisation?

Kinpeygo was granted conditional marketing authorisation in the EU on July 15, 2022.