Aegerion's Lomitapide Gets Orphan Drug Status From Japan's Health Authorities

(RTTNews) - Aegerion Pharmaceuticals, Inc. (AEGR) Monday said its lomitapide, used for the treatment of homozygous familial hypercholesterolemia or HoFH, has been granted orphan drug designation from Japan's Ministry of Labour, Health and Welfare. As required by the Japanese regulatory authorities, Aegerion is currently conducting a pharmacokinetic/pharmacodynamic study of lomitapide, which is expected to be complete in the fourth quarter of 2013. The Company then plans to conduct a small therapeutic study of lomitapide in Japanese adult HoFH patients.

Aegerion is currently conducting a pharmacokinetic/pharmacodynamic (PK/PD) study of lomitapide required by the Japanese regulatory authorities, expected to be completed in the fourth quarter of 2013. The Company then plans to conduct a small therapeutic study of lomitapide in Japanese adult HoFH patients.

"Japan's recognition of lomitapide as an orphan drug is important as we continue the ongoing clinical development work required for a future Japanese new drug application," said Marc Beer, Aegerion's Chief Executive Officer.