Aegerion expects to initiate pediatric study of lomitapide in 2014

theflyonthewall.com

Aegerion anticipates reimbursement decisions in some countries beginning in 2014. Aegerion has launched Lojuxta in the UK and Germany; however, limited uptake is expected until reimbursement decisions are made in those countries, which the company expects later this year. The company expects to initiate a therapeutic study of lomitapide in approximately 10 Japanese patients in Q1. The study is expected to support a potential Japanese New Drug Application. The company plans to initiate a therapeutic study of lomitapide in pediatric patients in 2014. Discussions with both the U.S. FDA and European Medicines Agency to finalize the trial protocol design are ongoing. Aegerion plans to submit regulatory filings for potential marketing approval of lomitapide in several additional international markets throughout 2014, and expects to continue to make lomitapide available on a named patient sales basis in certain countries, where possible.

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