Russia’s Ministry of Health has registered a new indication of Ivlizi (divozilimab), a drug which has been used for multiple sclerosis and systemic scleroderma treatment. Ivlizi, developed by the Russian company Biocad, is now allowed to be used in the treatment of Neuromyelitis optica, also called Devic’s disease, the manufacturer’s press service told GxP News.
“Divozilimab has become the first domestic original drug for the treatment of patients with Neuromyelitis optica registered in Russia,” the report says.
A clinical trial of Ivlizi with the participation of patients aged 18 to 76 years from Russia and Belarus showed a decrease in the intensity of the disease and the absence of exacerbations for 6 months in 90% of them, the company said.
According to Alexey Boyko, Vice President of the Russian Committee of Multiple Sclerosis Researchers, the drug is the first and only one indicated for the treatment of multiple sclerosis and neuromyelitis optica. “Given the high percentage of cross-diagnosis, from 20 to 40%, of these diseases, the registration of Ivlizi for the new indication can significantly improve the availability of modern therapy for patients,” the expert noted. The drug is included in the list of vital and essential drugs (VED).
Neuromyelitis optica is a rare autoimmune disorder that targets the central nervous system, causing inflammation of the optic nerves and spinal cord. This leads to damage to the optic nerves and spinal cord, resulting in irreversible impairments, including loss of vision and motor disorders. In Russia, neuromyelitis optica has the status of an orphan disease. It can lead to disability through repeated attacks on the optic nerves and spinal cord. Treatment goals focus on effectively managing acute episodes and on preventing future relapses, the press service emphasized.