November 14, 2013 / 5:10 PM / 4 years ago

CORRECTED-FDA panel says safety issues do not rule out Sanofi MS drug approval

(In Nov. 13 story “FDA advisory panel supports approval of Sanofi MS drug Lemtrada,” corrects headline and paragraph 1 to clarify that panel said safety concerns should not preclude approval; removes graph 1 reference to reserving drug for “patients who have failed other therapies”; corrects graph 2 to show vote was 17 to 0, not 14-0 and was to not rule out approval because of side effects, not to approve; adds Maryland to dateline)

SILVER SPRINGS, Maryland, Nov 13 (Reuters) - Safety problems associated with Sanofi SA’s experimental multiple sclerosis drug Lemtrada should not preclude approval of the drug, an advisory panel to the U.S. Food and Drug Administration said on Wednesday.

The panel voted 17 to 0, with one abstention, that the drug’s potential to cause cancer and other serious conditions was not a reason to prevent patients from gaining access to it.

“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 Alden Bentley

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