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By CNN
An
experimental drug showed positive results in three phase 3 trials for multiple
sclerosis, according to new research published Thursday in
the New England Journal of Medicine.
experimental drug showed positive results in three phase 3 trials for multiple
sclerosis, according to new research published Thursday in
the New England Journal of Medicine.
Phase
3 trials test the efficacy and safety of a new drug in human patients.
3 trials test the efficacy and safety of a new drug in human patients.
In
one phase 3 trial, patients with primary progressive MS who were given the
experimental drug ocrelizumab had less medical evidence and brain scan evidence
of disease progress compared to patients given a placebo.
one phase 3 trial, patients with primary progressive MS who were given the
experimental drug ocrelizumab had less medical evidence and brain scan evidence
of disease progress compared to patients given a placebo.
And
in two other, separate phase 3 trials, patients with relapsing forms of MS who
were given ocrelizumab showed lower rates of disease activity and progression
compared to patients receiving Interferon beta 1a, a standard MS treatment.
in two other, separate phase 3 trials, patients with relapsing forms of MS who
were given ocrelizumab showed lower rates of disease activity and progression
compared to patients receiving Interferon beta 1a, a standard MS treatment.
The
researchers caution that extended observation is required to determine the
long-term safety and efficacy of the drug.
researchers caution that extended observation is required to determine the
long-term safety and efficacy of the drug.
Ocrelizumab (Ocrevus) is under review by the
Food and Drug Administration for approval for both primary progressive and
relapsing MS. For the primary progressive multiple sclerosis indication, the
FDA has given Breakthrough Designation and priority review, in order to move up
the time line for potential approval.
Food and Drug Administration for approval for both primary progressive and
relapsing MS. For the primary progressive multiple sclerosis indication, the
FDA has given Breakthrough Designation and priority review, in order to move up
the time line for potential approval.
The
FDA does not comment on drugs that are under review. Still, the reason for an
expedited approval process seems obvious. It is needed.
FDA does not comment on drugs that are under review. Still, the reason for an
expedited approval process seems obvious. It is needed.
“No
treatments have been approved by the FDA for primary progressive MS,” said
Dr. Jack Burks, chief medical consultant for the Multiple Sclerosis Association of America. He
said only about 10% of the MS population is estimated to be diagnosed with the
primary progressive form of MS, but “this still represents tens of
thousands of individuals who currently have no available treatment
options.”
treatments have been approved by the FDA for primary progressive MS,” said
Dr. Jack Burks, chief medical consultant for the Multiple Sclerosis Association of America. He
said only about 10% of the MS population is estimated to be diagnosed with the
primary progressive form of MS, but “this still represents tens of
thousands of individuals who currently have no available treatment
options.”
How it works
Ocrelizumab selectively targets CD20-positive
B cells, a type of immune cell. B cells are thought to be a key contributor to
myelin (nerve cell insulation) and nerve cell damage, which can result in
disability for patients with MS, said Peter Chin, group medical director for
neuroscience at Genentech, the company
that makes the drug.
B cells, a type of immune cell. B cells are thought to be a key contributor to
myelin (nerve cell insulation) and nerve cell damage, which can result in
disability for patients with MS, said Peter Chin, group medical director for
neuroscience at Genentech, the company
that makes the drug.
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