The Food and Drug Administration has approved a controversial new drug for the fatal condition known as ALS, or Lou Gehrig's disease. The decision is being hailed by patients and their advocates, but questioned by some scientists.
of just 137 patients. Results suggested the drug might extend patients' lives by five to six months, or more.
"I totally understand why people would be trying to figure out a way to get this to patients," he says."There's just a general concern out there that maybe the trial is wrong." The second vote came after Dr. Billy Dunn, director of the FDA's Office of Neuroscience, encouraged the committee to exercise"flexibility" when considering a drug that might help people facing certain death.A negative result from that study would be a major blow to Amylyx and ALS patients.
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