SILVER SPRING Nov 13 Safety problems associated
with Sanofi SA's experimental multiple sclerosis drug
Lemtrada should not preclude approval of the drug, though it
should be restricted to patients who have failed other
therapies, an advisory panel to the U.S. Food and Drug
Administration said on Wednesday.
The panel voted 14 to 0, with one abstention, that the drug
should be approved.
"The risks are very substantial, but this is a really bad
disease," said Dr. Paul Rosenberg of Johns Hopkins University
School of Medicine.
The panel's recommendation follows an initial report by
reviewers for the FDA, who questioned whether the way the
clinical trials of Lemtrada were conducted biased the results in
favor of the drug.
The reviewers also raised grave concerns about the drug's
potential to cause an array of autoimmune conditions, in which
the body mistakenly attacks its own cells, as well as its
potential to cause thyroid, skin and breast cancer.
Multiple sclerosis is a chronic disease in which the body's
own immune system attacks the myelin sheaths that protect nerve
fibers in the brain, spinal cord and optic nerves. It can cause
a range of symptoms, including muscle weakness, speech and
visual disturbances, pain and cognitive difficulties.
(Reporting by Deborah Zabarenko; Editing by Leslie Adler)