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Biogen
Idec and Elan Pharmaceuticals announce Health Canada priority
review for Antegren®
Medical Update Memo
September 7, 2004
Summary
Biogen Idec and Elan Pharmaceuticals have announced that Health
Canada has granted a priority review to Antegren®;
(natalizumab). Antegren is a monoclonal antibody designed
to interfere with movement of potentially damaging immune
cells from the bloodstream across the blood brain barrier
into the brain and spinal cord. According to Dr. Paul O’Connor,
director, MS Clinic at St. Michael’s Hospital in Toronto,
who was quoted in the company news release, “Health
Canada has agreed to give priority review to a treatment
based on one-year trial data. The 2001 Phase II results were
very promising and demonstrated the ability of Antegren to
reduce MRI activity and the number of MS disease relapses.”
Details
There are several criteria which must be met in order for a
product to be accorded priority review status by Health Canada.
The drug must:
- provide a statistically significant and
clinically relevant improvement in efficacy or decrease in
risk over existing therapies on the Canadian market;
- be intended for patients suffering from
a serious, life-threatening or severely debilitating condition;
- be indicated to treat, prevent or diagnose
a serious symptom or manifestation of the condition.
Antegren is a monoclonal antibody that is
given by monthly infusion into a vein. It is designed to interfere
with the movement of potentially damaging immune cells from
the bloodstream, across the blood-brain barrier, and into the
brain and spinal cord. (The blood-brain barrier is a layer
of tightly connected cells that normally prevents large molecules
and cells from entering the brain.) Antegren blocks this movement
by attaching to alpha 4-integrin, a protein on the surface
of immune T cells which enables them to pass through the blood-brain
barrier. To date, approximately 2,800 people with MS have received
natalizumab in clinical studies.
The AFFIRM study of Antegren alone is a
two-year, placebo-controlled study involving approximately
900 participants in North America and Europe. It is designed
to determine whether natalizumab is effective in slowing the
rate of disability in MS and reducing the rate of MS attacks
when used alone.
The SENTINEL study of Antegren combined
with interferon beta-1a (Avonex®), or Avonex
combined with placebo, is a two-year, multi-centre study involving
approximately 1,200 participants. The SENTINEL study is designed
to determine whether the treatment of MS with natalizumab in
combination with Avonex is more effective than Avonex treatment
alone in slowing the rate of disability and relapses.
Because Health Canada has granted a priority
review halfway through the two-year clinical trials, the one-year
data submitted from the trials primarily address whether the
drug reduced relapse rates. The full, two-year trials are collecting
data on both relapse rates and on any slowing of the progression
of disability, as measured with the Expanded Disability Status
Scale (EDSS).
A previous six-month, placebo-controlled
trial of Antegren, involving 213 people with relapsing-remitting
MS or secondary-progressive MS with relapses, suggested that
the drug was well tolerated, reduced the accumulation of new
“enhancing” brain lesions detected by MRI, and
reduced the number of relapses. David H. Miller, MD (Institute
of Neurology, Queen Square, London) and colleagues reported
these findings in the January 2, 2003 issue of The New England
Journal of Medicine (2003;348:15-23).
ASK MS Information System Code:
1.4.1.12.2.n
National Research Department
National Communications & Government Relations Department
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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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