In Russia, the third phase of clinical tests of bioanalogue of the drug for the treatment of immune thrombocytopenia has ended. This disease is characterized by the fact that the immune system destroys platelets responsible for blood coagulation. This leads to increased risk of bleeding and the formation of bruises.
The new drug, GP40141, is an analogue of the original ENPLET drug, which is included in the list of vital drugs. The Russian version is designed to provide patients with a more affordable therapeutic option.
The study was conducted with the participation of 136 patients from 16 medical centers. Some of the subjects were received by bioanalog, and the other was the original drug. The results showed comparable efficiency and safety of the Russian medicine.
A feature of the study was the transition of patients from the original drug to an analogue. This allowed scientists to confirm not only effectiveness, but also the safety of such a replacement.
The drug has already received a registration certificate.
