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 she'll 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.
Bass led the fight to get the FDA to reconsider its denial and was part of a letter-writing campaign that even Gallagher participated in. Now she feels vindicated for all her passion. "When we started out with this treating the first patient in the U.S. in 2002, we never thought, you know, here we are a decade later, that we would be able to treat the first patient in the U.S. after FDA approval. I'm just so thankful and grateful to have this opportunity for my patients."
She estimates that one third of all MS patients will try the newly approved drug.