Safety of generic fingolimod
https://doi.org/10.30895/2312-7821-2018-6-1-23-31
Abstract
Generic drug of fingolimode (Nesklair, Russia) receives marketing authorisation in 2014. In 2016, was initiated the Post-authorisation safety study (PASS) to evaluate the safety of Neskler in patients with remitting multiple sclerosis (MS) vs. original drug and in the primary assignment. This PASS was conducted at 8 clinical centres in 7 regions of Russia — Moscow, Moscow region, St. Petersburg, Rostov-on-Don, Ufa, Chelyabinsk, Kurgan. The results of therapy of MS in 94 patients of both sexes, aged 35 ± 8.9 years, who have got fingolimode for 12 months are presented. The average duration of disease at inclusion in the study was 8.6 ± 4.9 years. 74,47 per cent (1 group) received this therapy with the original drug, 25.53 per cent of patients (group 2) have not received previous fingolimode. The results of the program indicate a good safety profile, comparable with previously published data on the use of the original drug.
About the Authors
O. M. Koval
Clinical Trails and Healthcare Technology Assessment of Moscow Department of Healthcare.
Russian Federation
Russian Federation
Koval Olga M. Head of the Division of Clinical Studies.
N. V. Khachanova
Russian National Research Medical University named after N.I. Pirogov.
Russian Federation
Russian Federation
Khachanova Natalia V. Professor of the Department of Neurology, Neurosurgery and Medical Genetics, PhD, prof.
M. V. Zhuravleva
I.M. Sechenov First Moscow State Medical University.
Russian Federation
Russian Federation
Zhuravleva Marina V. Professor of the Department of Clinical Pharmacology, Chief freelance specialist clinical pharmacologist Department of health of Moscow, MD, PhS, DSc, prof.
A. G. Fisun
Clinical Trails and Healthcare Technology Assessment of Moscow Department of Healthcare.
Russian Federation
Fisun Anna G. Junior researcher of the scientific and clinical department.
Russian Federation
Fisun Anna G. Junior researcher of the scientific and clinical department.
M. V. Davydovskaya
Clinical Trails and Healthcare Technology Assessment of Moscow Department of Healthcare.
Russian Federation
Russian Federation
Davydovskaya Maria V. Deputy Director on Scientific Work, Deputy chief off-staff specialist neurologist, Department of Health of Moscow, MD, PhS, DSc, prof.
K. A. Kokushkin
Clinical Trails and Healthcare Technology Assessment of Moscow Department of Healthcare.
Russian Federation
Russian Federation
Kokushkin Konstantin A. Director.
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Review
For citations:
Koval O.M., Khachanova N.V., Zhuravleva M.V., Fisun A.G., Davydovskaya M.V., Kokushkin K.A. Safety of generic fingolimod. Safety and Risk of Pharmacotherapy. 2018;6(1):23-31. (In Russ.) https://doi.org/10.30895/2312-7821-2018-6-1-23-31
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