A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
Phase of Trial: Phase II
Latest Information Update: 12 Jun 2018
At a glance
- Drugs Idebenone (Primary)
- Indications Leber's hereditary optic atrophy
- Focus Registrational; Therapeutic Use
- Acronyms RHODOS-OFU
- Sponsors Santhera Pharmaceuticals
- 12 Jun 2018 According to a Santhera Pharmaceuticals media release, 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). This filing is based on the data package filed in the European MAA.
- 01 Sep 2015 According to a company media release, Santhera Pharmaceuticals re-filed a Marketing Authorization Application (MAA) and in June 2015, the CHMP recommended granting a marketing authorization for Raxone for the treatment of visual impairment in adolescent and adult patients with LHON.
- 22 Jan 2013 New trial record