STADA and Calliditas announce the filing for full marketing authorization of Kinpeygo® in the EU

• Request submitted by STADA to EMA to convert conditional marketing authorization to standard marketing authorization for Kinpeygo treatment for primary IgA nephropathy           

• Submission to the CHMP for full approval is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet         

• Kinpeygo is the first and only approved treatment in Europe for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.

BAD VILBEL, Germany and STOCKHOLM, Sept. 28, 2023 /PRNewswire/ -- Partners STADA and Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced the submission of a request to the European Medicines Agency (EMA) for the Committee for Medicinal Products for Human Use (CHMP) to convert the conditional marketing authorization for Kinpeygo®, their treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. This was granted in the interest of public health because the medicine addresses an unmet medical need, and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required.

Kinpeygo is the first and only approved treatment in Europe for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. STADA, which holds European commercial rights, already launched the IgAN medicine in Germany in September 2022 and is working to extend patient access to other countries.

The submission to the CHMP for full approval is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet^[1]. This randomized, double-blind, multicenter study assessed the efficacy and safety of Kinpeygo - developed under the project name Nefecon® - dosed at 16 mg once daily versus placebo on a background of optimized renin-angiotensin system inhibitor (RASi) therapy in adult patients with primary IgAN. The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9 months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug.

"By filing for a standard marketing authorization with the EMA, based on the full dataset as published in the Lancet journal, STADA and Calliditas are optimistic about bringing this important Specialty therapy for unmet medical need in chronic kidney disease to more people with IgAN in Europe," commented STADA's Head of Global Specialty, Bryan Kim.

"The eGFR treatment benefit observed across the entire study population, irrespective of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment that holds the promise of being disease modifying. We are pleased to be able to provide the EMA with the full results of our Phase 3 study, and we look forward to interactions with the regulatory agency regarding full approval of Kinpeygo," stated Renée Aguiar-Lucander, Chief Executive Officer of Calliditas Therapeutics.

^[1]   Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial - The Lancet

CONTACT:

For further information, please contact:

Åsa Hillsten, Head of Investor Relations & 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 persons set out above, on September 28, 2023 at 12:00 p.m. CET.

STADA information for journalists:

STADA Arzneimittel AG - Media Relations
Stadastrasse 2-18
61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165
E-Mail: press@stada.de
www.stada.com/press

STADA information for capital market participants:

STADA Arzneimittel AG - Investor & Creditor Relations
Stadastrasse 2-18
61118 Bad Vilbel – Germany
Phone: +49 (0) 6101 603-4689
Fax: +49 (0) 6101 603-215
E-mail: ir@stada.de
www.stada.com/investor-relations 

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