|
FDA approves Tysabri's return
to market in U.S. for relapsing MS
Click
here to view or print this bulletin in its original format.
Medical Update Memo
June 9, 2006
Summary
The Food and Drug Administration (FDA) has approved the return
to market in the United States of Tysabri® (natalizumab)
as a therapy for people with relapsing multiple sclerosis.
The approval is based on positive results from two clinical
trials showing that Tysabri significantly reduced the risk
of sustained progression of disability and the rate of clinical
relapse in people with relapsing MS. It follows an extensive
FDA review of the product after the withdrawal of Tysabri
from the market in 2005 because of safety concerns. In
Canada, Tysabri is currently under priority review by Health
Canada.
Details
The FDA approval of Tysabri to re-enter the US market
requires a mandatory registration program for both people who
take the drug and their prescribing physicians to minimize
the risks that patients will develop PML (progressive multifocal
leukoencephalopathy), caused by a common virus called the JC
virus. Three people who had been in clinical trials involving
Tysabri developed PML, two of whom died. The identification
of PML in people who had taken Tysabri resulted in the drug
being withdrawn from the US market in 2005. The drug, which
is taken by monthly intravenous (into the vein) infusion, will
be dispensed at registered infusion centres across the United
States.
Tysabri is generally recommended for people
who have had inadequate response to, or are unable to tolerate,
other approved MS therapies (such as Copaxone®, Betaseron®,
Avonex®, Rebif®, and Novantrone®). It is approved
as a monotherapy (single therapy), not to be combined with
other immune system-modifying agents, and is not recommended
for individuals who have compromised (weakened) immune systems.
Biogen Idec and Elan Pharmaceuticals, the
companies that produce Tysabri, hope to commercially launch
it or make it available for use in the United States in July
2006. As part of the FDA approval, the companies have agreed
to conduct a post-marketing study that will follow some 5,000
people with MS prescribed Tysabri for five years to evaluate
the long-term safety of the drug in the clinical practice setting.
Key aspects of the approval include:
-
Tysabri is approved to delay the accumulation
of physical disability and reduce the frequency of clinical
exacerbations (flare-ups or relapses) in patients diagnosed
with relapsing MS;
-
Tysabri will only be available under
a restricted distribution program called TOUCH, and prescribing
physicians and patients must enrol in this mandatory registry
program;
-
Tysabri can be given only at registered
infusion centres where the medical personnel have been
trained in its proper use and in the risks of PML;
-
Tysabri should be given as a monotherapy,
meaning it should not be combined with other medications
that alter immune function;
-
Tysabri is generally recommended for
patients who have had inadequate response to, or are unable
to tolerate, other approved MS therapies;
-
Tysabri is not recommended for patients
who have compromised (weakened) immune systems or who are
taking other drugs that suppress or modulate the immune
system, with the exception of periodic steroids to treat
relapses;
-
Prescribing information carries a “Black
Box Warning” to highlight the increased risk of PML
and the importance of monitoring patients for any new signs
or symptoms that may be suggestive of PML;
-
An MRI scan should be obtained prior
to starting treatment with Tysabri;
-
Prior to each infusion, the patient
and infusion nurse complete a checklist to identify any
new neurological signs or symptoms that require evaluation
by a physician; and
-
Patients on TyZsabri are to be evaluated
by the prescribing physician three and six months after
the first infusion and every six months thereafter.
The Multiple Sclerosis Society of Canada
is looking forward to having Tysabri available as a treatment
choice for Canadians with MS if it passes Health Canada’s
strict safety and efficacy guidelines. Currently, Tysabri is
undergoing priority review by Health Canada. The MS Society
will closely monitor the Health Canada process.
[With information from the National MS Society
(USA)]
ASK MS Information System Code: 1.4.1.60.5.b
National Research Department
National Marketing and Communications Department
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.
Back
to top |
