Santhera Pharmaceuticals said on Tuesday that the Korean Ministry of Food and Drug Safety (MFDS) has accepted its new drug application (NDA) for Raxone for review, regarding the treatment of Leber’s hereditary optic neuropathy (LHON). Raxone was granted orphan drug designation for LHON in South Korea.
The SIX Swiss Exchange listed company’s 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.
Santhera said that the NDA now submitted to the MFDS was prepared on the basis of the European marketing authorization and that the decision from the South Korean drug regulatory authorities should arrive in about one year.
Santhera’s CEO, Thomas Meier, said that the regulatory submission of Raxone for LHON in South Korea, one of the major Asian markets, underlines the company’s geographical expansion and its commitment to providing treatment to patients worldwide, addressing a major unmet medical need in this rare disease.
Santhera added that 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.