STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA.
NORDIC BUSINESS REPORT-October 3, 2023-STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
(C)2023 M2 COMMUNICATIONS http://www.m2.co.uk
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...
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