The Food and Drug Administration on Tuesday granted conditional approval to a new treatment for a rare, genetic form of ALS — basing its decision for the first time on preliminary evidence that may also speed the development of future medicines for the fatal, neurodegenerative disease.
The new drug, called Qalsody, is made by Biogen.
The medicine, administered by a monthly injection into the spine, is intended to treat people with ALS caused by inherited mutations in a gene called SOD1. Biogen estimates approximately 330 people in the U.S. have this form of ALS, with 120 new cases each year. Globally, SOD1 mutations are responsible for approximately 2% of all ALS cases.
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