Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Rhea-AI Summary

Calliditas partner STADA submits request for full marketing authorization for Kinpeygo in the UK for IgA nephropathy.

Positive

• STADA has submitted a request to the MHRA for full marketing authorization for Kinpeygo, a treatment for IgA nephropathy.
• Kinpeygo is the first and only approved treatment for IgA nephropathy in the UK.
• The submission is based on positive Phase 3 trial results, with Kinpeygo demonstrating a highly statistically significant benefit over placebo in estimated glomerular filtration rate.

Negative

• None.

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. 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. STADA, which holds the commercial rights in the European Economic Area (EEA) member states, Switzerland and the UK, has already launched the IgAN medicine in Germany in September 2022 and is working to extend patient access to other countries.

The submission to the MHRA for full approval, made by STADA's affiliate Britannia Pharmaceuticals Ltd., 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]. 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 nine months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug.

^[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

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 October 3, 2023 at 09:20 a.m. CET.

The following files are available for download:

https://mb.cision.com/Main/16574/3846738/2334379.pdf

Kinpeygo UK Full Approval Filing PR_ENG

 

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SOURCE Calliditas Therapeutics