Pratteln, Switzerland, June 12, 2018 - Santhera Pharmaceuticals (SIX: SANN) announces that the Korean Ministry of Food and Drug Safety (MFDS) has accepted for review Santhera's new drug application (NDA) for Raxone® (idebenone) for the treatment of Leber's hereditary optic neuropathy (LHON). Raxone was granted orphan drug designation for LHON in South Korea.
Raxone® (idebenone) is an oral medication, currently authorized in the European Union, Norway, Iceland, Liechtenstein and Israel at a daily dose of 900 mg for the treatment of visual impairment in adolescent and adult patients with LHON. It is the first and only medicine approved for this rare inherited disease which, if untreated, invariably leads to profound vision loss and blindness.
The NDA now submitted to the MFDS was prepared on the basis of the European marketing authorization and Santhera expects a decision from the South Korean drug regulatory authorities in approximately one year.
"The regulatory submission of Raxone for LHON in South Korea, one of the major Asian markets, underlines our geographical expansion and our commitment to providing treatment to patients worldwide, addressing a major unmet medical need in this rare disease," said Thomas Meier, PhD, CEO of Santhera.
Raxone has also been granted orphan drug designation for LHON in South Korea, which provides up to 10 years market exclusivity from the date of approval.