Developers: | Biocad |
Date of the premiere of the system: | 2023/04/21 |
Branches: | Pharmaceuticals, Medicine, Healthcare |
Main article: Multiple sclerosis
2023: Registration of the Russian drug "Tenexia" for the therapy of multiple sclerosis
The Ministry of Health of the Russian Federation has registered Russian pegylated interferon beta-1a for the therapy of multiple sclerosis, created by scientists from the biotechnological company BIOCAD. The innovative development received the trade name Tenexia. INN: sampeginterferon beta-1a. This was announced on April 21, 2023 by BIOCAD.
Tenexia is next-in-class and is pegylated interferon for the treatment of patients with remitting multiple sclerosis, the most common type of disease course. medicinal product It took 10 years to develop, preclinical and clinical studies. BIOCAD began work on this project back in 2012. The volume market of pegylated interferons for the treatment of multiple sclerosis is about 2 billion. rubles
A feature of the first Russian pegylated interferon beta-1a for the therapy of multiple sclerosis was conjugation with a polyethylene glycol (PEG) molecule with a molecular weight of 30 kDa, which made it possible to improve the pharmacokinetic characteristics of the drug, increase the duration of the effect of interferon on the body, and therefore reduce the frequency of drug administration to once every two weeks. The drug has an intramuscular route of administration, which may reduce the incidence of adverse events such as local reactions in places, injections narrated by Pavel Yakovlev, vice president of early development and research at BIOCAD.
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Tenexia has become the eleventh original drug in BIOCAD's portfolio.
Innovative development has been studied in a number of physicochemical, preclinical and clinical studies. Studies of the drug were carried out as part of the implementation of a state contract for a total amount of 42.6 million rubles. The basis for the registration study was 30 research centers in Russia, as well as in the Republic of Belarus. About 400 patients with multiple sclerosis participated in clinical studies. During the studies, there was an improvement in the course of the disease in patients, a decrease in the number of exacerbations and an increase in the level of adherence to therapy.
Multiple sclerosis is a chronic autoimmune disease in which the myelin sheath of the nerve fibers of the brain and spinal cord is affected and degenerative changes occur in the central nervous system. Multiple sclerosis can lead to impaired motor activity, paresis and complete paralysis. Young and middle-aged people are susceptible to the disease.