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The UK MHRA has granted marketing authorisation to Arrowhead Pharmaceuticals’ Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronaemia syndrome (FCS), diagnosed via genetic testing or clinical criteria
NICE has also issued guidance recommending NHS funding in England & Wales for adults with genetically confirmed FCS whose response to diet & conventional TG-lowering therapies is inadequate, under a commercial arrangement
Approval was based on the P-III (PALISADE) trial in 75 adults with FCS, in which Redemplo (25mg) significantly reduced median fasting TGs vs PBO at Mos. 10 (p<0.0001); Redemplo is administered SC once every 3 months
Ref: Arrowhead Pharmaceuticals | Image: Arrowhead Pharmaceuticals | Press Release
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The post Arrowhead Receives the UK MHRA’s Approval and NICE Recommendation for Redemplo (Plozasiran) to Treat Familial Chylomicronaemia Syndrome appeared first on PharmaShots.
Arrowhead Receives the UK MHRA’s Approval and NICE Recommendation for Redemplo (Plozasiran) to Treat Familial Chylomicronaemia Syndrome | PharmaVoice