Serious Infections Experienced by Two
People Participating in Clinical Trials of FTY720 for MS
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Medical Update Memo
June 13, 2008
SUMMARY
Two people participating in clinical trials
of the experimental oral medication FTY720
(Novartis Pharmaceuticals Corp.) for the
treatment of multiple sclerosis were reported
to develop severe infections – one
of which resulted in a death.
Details
Fingolimod, also known as FTY 720, is a drug
in phase 3 studies after showing promise in
earlier studies. There are approximately 3,000
people enrolled in multiple studies worldwide.
Both cases involved confounding factors, including
the use of very high doses of steroids in one
patient and the delayed use of antiviral therapy
in the other.
The independent safety monitoring committee
overseeing the clinical trials has recommended
that the trials proceed. Participants will
be informed of the occurrence of these infections
and will be asked to give their consent again
to continue in the study. In addition, Novartis
states that it is in active discussions with
health authorities and other experts to develop
measures that will enhance patient and investigator
awareness regarding the risk of infections
and how these risks may be reduced.
All individuals participating in clinical
trials of FTY720 are advised to contact their
study coordinators for more information.
Since MS is driven by immune system attacks,
researchers have to strike a difficult balance
of turning down the MS attack without stifling
the immune system’s ability to fight
infection.
With information from the National MS Society
(USA)
ASK MS Information System Code: 1.4.1.75.g
National Client Services
Medical Information and Education
Offert en
français.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy,
but provides information to assist individuals in making their own decisions.
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