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.
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By GlobalDataAmryt 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.
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