Barzilai University Medical Center/Ben Gurion University of the Negev
Neurology

Author Of 1 Presentation

Disease Modifying Therapies – Risk Management Poster Presentation

P0405 - The consequences of switching from Gilenya to generics for Fingolimod (ID 1129)

Speakers
Presentation Number
P0405
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

On May 2017, two generic drugs for fingolimod were introduced into the market in Israel, and many MS patients treated with Gilenya (Novartis) were switched to Fingolimod (Teva), or to Finolim (Rafa).

Objectives

To analyze the consequences of switching from original Gilenya to generic fingolimod preparations in a single MS center.

Methods

Inclusion criteria included relapsing MS patients who were treated with Gilenya (G) for at least one year before May 2017, switched to and remained on generic fingolimod (F) for at least one year thereafter. Retrospective data within one year before and after the switch were compared.

Results

Twenty seven patients fulfilled the inclusion criteria (F=20, RRMS=20, SPMS=7, average age 49±11.4, average disease duration=16.6±7.6 years). Ten patients had to be switched back to the original Gilenya by the request of their neurologist due to intolerable new or worsening adverse events (n=9), clinical relapse (n=1), or elevation of liver enzymes > X3 ULN (n=1). Liver enzyme abnormalities were detected in 2/27 patients during G treatment and in 4/27 during F treatment (p=NS). There was a trend towards reduced lymphocyte count after G-F switch (644±221 vs. 593±182, p=0.149). Median EDSS increased from 2.75 (1.0-6.0) to 3.0 (1.5-6.5) (p=NS). Age, disease duration and disease type (RRMS or SPMS) did not predict the need for switching back to G.

Conclusions

The tolerability of generics for fingolimod seems to be lower than the original Gilenya. Despite the small number of patients, short follow-up period and the minor or no differences between F and G treated patients detected in most parameters which do not allow for drawing definite conclusions regarding the comparative efficacy and safety of G and F, these results raise concerns about the use of generics, even for simple chemical drugs such as fingolimod, in a complex and heterogenous disease such as MS that spans over many domains. This may suggest that pharmacodynamic and clinical evaluations, not merely the demonstration of bioequivalence, are needed before approving generic drugs for MS.

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