Makers of MS drug to try again for FDA approval

by: Diana Davis Updated:


ATLANTA - The company behind a potential breakthrough drug for multiple sclerosis says they will try again for approval.
The FDA refused to approve the drug a few months ago.
Channels 2’s Diana Davis talked with a patient and doctor who said the drug is many patients' last hope.
Destiny Ward, 22, said she found out when she was 12 that she had multiple sclerosis, an inflammatory disease that attacks the cells of the spinal cord and brain.
Ward told Davis the symptoms have come and gone for years.
“I went blind, I went deaf. It comes and goes at different times where you're not sure when it’s going to happen,” Ward said.
MS affects about 400,000 Americans.
Blurred vision, slurred speech, fatigue and memory problems can be disabling.
The disease has affected Ward’s balance. She often stumbles and falls and drags one of her legs. She says the pain is sometimes unbearable.
“Every night I go to sleep in pain. Every day I wake up in pain,” Ward said.
There is no cure for MS but there are nearly a dozen FDA approved drugs to treat some of the symptoms.
Ward’s doctors have tried all the usual drugs for MS and at first they did help. But now they've lost their effectiveness.
Lemtrada was Ward’s last hope. It was recently approved for use in Europe, Australia and Canada, but the FDA wouldn’t approve it in the U.S., saying it was concerned about potential risks.
The news has devastated patients like Ward and frustrated doctors.         
“It’s very difficult when you know there's something available that could have a significant impact on your patients and you have to watch them get worse because it’s not available,” said Dr. Jeffrey English of the MS Center of Atlanta.
Even if the FDA eventually approves Lemtrada, doctors said the process could take months. That’s time that some MS patients don’t have, said English.
“We are really on the edge with patients like her (Ward) who are getting worse and they will have significant permanent impairment,” English said.
“This  is my only hope,” Ward said.

An online petition has been started urging the FDA to approve Lemtrada.

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