STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
3 October 2023 -

Swedish commercial stage biopharma company Calliditas Therapeutics AB (Nasdaq: CALT) (STO: CALTX) announced on Tuesday that its partner STADA Arzneimittel AG (STADA) (FWB: SAZ) has applied to the UK MHRA to upgrade the conditional marketing authorization for Kinpeygo, a treatment for primary IgA nephropathy (IgAN), to full marketing authorization.

Kinpeygo, the sole UK-approved IgAN treatment, currently holds conditional approval for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression, and STADA, with commercial rights in EEA member states, Switzerland, and the UK, launched it in Germany in September 2022. STADA plans to expand patient access to other nations.

This submission to the MHRA, facilitated by STADA's affiliate Britannia Pharmaceuticals Ltd., relies on the complete two-year data set from the Phase 3 NefIgArd clinical trial, recently featured in The Lancet. The trial conclusively demonstrated Kinpeygo's superiority over placebo in estimated glomerular filtration rate (eGFR) over the two-year span, involving nine months of treatment and a 15-month follow-up period post-treatment cessation (p value < 0.0001).

Stada Arzneimittel AG is a German pharmaceutical company which specializes on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma.