New Russian drug for the treatment of multiple sclerosis

Generium has received marketing authorization for Efictel (INN: natalizumab). This is the first Russian analogue of Biogen's American drug Tysabri for the treatment of adult patients with highly active forms of relapsing-remitting multiple sclerosis (MS). It is included in the Vital and Essential Drugs List.   

The entire production cycle for Efiktel will be carried out by Generium in the Vladimir region. 

Multiple sclerosis is a disease in which the immune system attacks the brain and spinal cord, causing inflammation and damaging nerve cells. 

Symptoms of multiple sclerosis vary among patients and depend on the location and severity of nerve damage. They often include vision problems, fatigue, gait and balance difficulties, as well as numbness and weakness in the arms and legs. Symptoms may come and go or persist for a long time.  

The causes of multiple sclerosis are unknown, but the risk of developing it may be increased by having relatives with multiple sclerosis.  

Natalizumab is a monoclonal antibody that acts as a "key" that locks a "door" for immune cells. This "door" is the α4β1 integrin protein (cellular "stickers" and "communications" that ensure cell adhesion to each other and to surrounding tissues and transmit signals from the outside to the inside of the cell, thereby determining the cell's actions (division, movement). Natalizumab medications prevent mononuclear leukocytes from leaving blood vessels and penetrating inflamed organ tissue, thereby suppressing inflammatory activity in the affected tissues and further recruitment of immune cells to the site of inflammation.  

The results of a comparative study demonstrating the safety, efficacy, and immunogenicity of Efictel and Tysabri served as the basis for the drug's registration. The study involved 330 patients from more than 30 hospitals and medical centers across Russia, including renowned institutions in Moscow and Tomsk.