Re: Elan shares jump 25% on Tysabri news.
- From: "rose" <rosedawn_scott@xxxxxxxxx>
- Date: 9 Mar 2006 08:46:10 -0800
Ross M. Greenberg wrote:
http://business.scotsman.com/latest.cfm?id=357242006
more info for non-investor patients from the NMSS regarding the
Committee recommendations, and what they might mean for those patients
and docs who want to use it --
---------------
March 8 Update: FDA Advisory Panel Recommends Tysabri's Return To
Market For Relapsing MS
An FDA advisory committee today recommended that Tysabri (natalizumab,
Biogen Idec and Elan Pharmaceuticals) be approved for return to market
for the treatment of relapsing multiple sclerosis. While the FDA is not
required to follow the recommendations of its advisory committees, it
usually does. The agency is expected to make a final decision about
whether to approve the drug for market by the end of March 2006.
For two days, March 7-8, 2006 , an FDA advisory committee met to
evaluate whether Tysabri can safely return to market following its
withdrawal due to safety concerns in February 2005. The committee
reviewed data about the drug's effectiveness and its side effects, the
proposed risk management plan developed by the drug's sponsors and the
FDA's assessment of the safety and efficacy of the drug and risk
management issues. The committee also heard extensive public testimony
from concerned citizens and patient groups.
A primary safety issue examined by the committee was the fact that
three people who had been in clinical trials involving Tysabri
developed a rare disease called PML (progressive multifocal
leukoencephalopathy), caused by a common virus called the JC virus. Two
of them died, including one person with MS.
The advisory committee recommended that Tysabri be approved for return
to market for the treatment of relapsing multiple sclerosis. Its key
recommendations for approval include:
· Tysabri be made available only to patients who have enrolled along
with their physicians in a mandatory registry program;
· Tysabri be made available only to patients diagnosed with
relapsing MS;
· Tysabri be given only at authorized infusion centers where the
medical personnel have been trained in its proper use and in the risks
of PML;
· Tysabri not be used in patients who have compromised immune
systems or who are taking other immunosuppressive or immunomodulatory
agents, with the possible exception of periodic steroids to treat
relapses;
· prescribing information carry a "black box warning" concerning
PML;
· prior to starting treatment, the physician complete a "patient
checklist" to ensure that the patient meets all requirements for use
of Tysabri; and
· prior to each infusion, the patient and infusion nurse complete a
checklist to screen for symptoms suggestive of PML.
The advisory committee did not achieve consensus on any recommendation
of whether Tysabri should be used as a "first-line" therapy or
whether a patient must first be on another disease-modifying therapy
that proved ineffective.
National MS Society Position Statement
The National MS Society is relentless in our pursuit of the goal of
giving people with MS more choices for safe and effective treatments.
We applaud the FDA advisory committee's efforts and findings. It is our
expectation that the FDA will agree with the committee's
recommendations and return Tysabri to market.
The Society will continue to provide its members and the public the
best available information regarding any developments through our Web
site (www.NationalMSSociety.org/Tysabri). Once a determination is
reached, we will do everything possible to ensure that people with MS
fully understand the decision.
---------------
looks like the Committee (their rec's aren't always followed to the
letter by the FDA...but they usually are) is recommending Tysabri be
re-intro'd for RRMS patients only -- they've got "for Relapsing M.S."
right there -- if that *is* the case, then it won't be available to me
anyway. heh, makes the Big Decision -- Tysabri or more Novantrone? -- a
lot easier, at least, i guess.
rose
.
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- From: Ross M. Greenberg
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