Safety of generic fingolimod
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 w...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
2018-03-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/96 |
| Summary: | 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. |
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| ISSN: | 2312-7821 2619-1164 |