Arrowhead’s Redemplo gains UK approval and NHS funding recommendation
The UK MHRA granted marketing authorisation for Arrowhead Pharmaceuticals’ REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome. NICE recommended NHS funding in England and Wales for genetically confirmed adults whose response to diet and conventional therapies is inadequate, under a commercial arrangement. The decision was supported by the PALISADE Phase 3 placebo-controlled study of 75 adults.
Why it matters
The authorisation allows UK marketing, while the NICE recommendation creates an NHS funding route for eligible patients in England and Wales. Northern Ireland and Scotland retain separate reimbursement processes, so access will not be uniform across the UK.
Key facts
- 1MHRA authorisation covers adult FCS patients diagnosed through genetic testing or clinical criteria. stocktitan.net
- 2NICE recommended NHS funding in England and Wales for genetically confirmed adults whose response to diet and conventional triglyceride-lowering therapies is inadequate. finanznachrichten.de
- 3The PALISADE Phase 3 placebo-controlled study evaluated plozasiran in 75 adults with genetically confirmed or clinically diagnosed FCS. finanznachrichten.de
- 4REDEMPLO marketing authorisation applies across the United Kingdom, while the NICE guidance formally applies to England and Wales. pharmaceutical-technology.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.