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April 7, 2021

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

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.

By Reynald Castañeda

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.

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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.

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What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
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