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LoA Update: Amryt’s Juxtapid sees 7-point surge in US approval prospects in familial chylomicronaemia due to positive investigator-led Phase III trial

By Reynald Castaneda 07 Apr 2021 (Last Updated April 7th, 2021 12:56)

Amryt Pharma’s Juxtapid (lomitapide) had a 7-point jump in its Likelihood of Approval (LoA) in familial chylomicronaemia syndrome (FCS) on the heels of positive data from an investigator-led Phase III trial.

LoA Update: Amryt’s Juxtapid sees 7-point surge in US approval prospects in familial chylomicronaemia due to positive investigator-led Phase III trial
Juxtapid is FDA and EMA-approved for use in homozygous familial hypercholesterolemia as a cholesterol reduction agent. Credit: Grycaj/Shutterstock.com.

Amryt Pharma’s Juxtapid (lomitapide) had a 7-point jump in its Likelihood of Approval (LoA) in familial chylomicronaemia syndrome (FCS) on the heels of positive data from an investigator-led Phase III trial. Juxtapid’s updated LoA is 36%, which is an increase from 29%, as of 31 March, according to GlobalData analysis that uses a combination of machine learning and a proprietary algorithm.

The Phase III LOCHNES trial reported results on 30 March. In the open-label study, 14 out of 18 patients achieved a reduction in triglycerides to less than 1000mg/dL, with 13 of these patients having 750mg/dL or below at 26 weeks. The median baseline fasting triglyceride in all patients was 1885 mg/dL. FCS patients have compromised enzyme lipoprotein lipase, which leads to elevated triglyceride levels.

Amryt said it will evaluate full LOCHNES data and discuss the potential development path of Juxtapid in this indication with the FDA and EMA. Juxtapid is FDA and EMA-approved for use in homozygous familial hypercholesterolemia as a cholesterol reduction agent. Juxtapid is under the name Lojuxta in the EU.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.