SA tested MS drug approved by FDA

NEWS

FDA reverses its denial of approval on lemtrada, opening the door for many MS patients

Posted YESTERDAY, 7:04 PM Updated YESTERDAY, 7:04 PM

SAN ANTONIO - One year after denying approval and shocking the multiple sclerosis medical community, the Food and Drug Administration has reconsidered the fate of Lemtrada, a three-year MS treatment infusion that was first tested in San Antonio and proven effective.

The Neurology Center of San Antonio offered the first clinical trial in the country 12 years ago, and spearheaded efforts for full approval by the FDA. In 2013, approval denied in large part because test subjects had not been given placebo medication, a practice that MS doctors say would have been cruel with the knowledge that refusing a patient the effective drug would have resulted in MS relapses in which they perhaps would not have recovered.

Dr. Ann Bass, the MS specialist at the center, explained what happens next. "The actual drug will be made available Dec. 5, so the paperwork goes in and the drug becomes available right away."

Her Patient One, Cheryl Gallagher, will start treatment immediately.

Gallagher has had MS for 18 years and lost sight in one eye. Other drugs no longer work and she fears shell lose sight in her other eye.

She said she is looking forward to trying the drug."That would be wonderful. I'm hoping that's what's going to work for me," She said.

Lemtrada patients will be placed on an IV transfusion for four hours on a five day stretch. They will be closely monitored for thyroid and other changes, but basically the medicine does its work for a year after that. For the next two years there is a three day infusion annually.

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SA tested MS drug approved by FDA