docs.healthdata.beProject name
Real world data collection on the efficacy and drug usage of Raxone 150 mg 180 film-coated tablets for treatment of reduced vision in adolescent and adult patients with Leber’s hereditary optic neuropathy
Project abbreviation
Raxone MEA
Project code
HDP0239
Primary organization that oversees implementation of project
- Chiesi Pharmaceuticals
Partner organization participating in project
- Not applicable
Organization that commissioned this project
- National Institute for Health and Disability Insurance (RIZIV-INAMI)
Organization providing monetary or material support
- Chiesi Pharmaceuticals
Brief project description
"Leber’s hereditary optic neuropathy (LHON) is a genetic disease that leads to sudden vision loss during young adult life. LHON is a disorder caused by mutations in the genetic code of the mitochondria, which are small subunits that reside within the cell. Mitochondria constantly convert energy locked in our food into energy that the cell can use.
Brain cells, including the optic nerves, which are particularly energy-demanding, are therefore, more prone to damage if the mitochondria are not able to produce energy properly. A lack of energy production can lead to degeneration and death of retinal ganglion cells (RGCs), which are the nerve cells that communicate visual information to the brain. Loss of these cells leads to subsequent degeneration of the optic nerve and visual loss.
An agreement with Chiesi for the temporary registration of a proprietary medicinal product on the list of reimbursable proprietary medicinal products, in accordance with the provisions of articles 112 to 117 inclusive of the royal decree of 1 February 2018 has been established with the working group for agreements (RIZIV/INAMI) and the Minister of Social Affairs. During the temporary reimbursement of 2 years, the company has to answer 6 questions (included in the agreement) to give an answer to the uncertainties that there are today."
Regulatory framework of this project
Consult the regulatory framework information published on the fair.healthdata.be pages.