FDA approves first drug to target a genetic cause of ALS – it’s from Biogen

RESEARCH TRIANGLE PARK – The U.S Food and Drug Administration has approved Biogen’s ALS drug QALSODY, Tuesday afternoon. The drug is used for treating the neurological disorder of amyotrophic lateral sclerosis (ALS) found in adults who have a mutation in the superoxide dismutase 1 (SOD) gene.

Qalsody is the first approved treatment in history to target a genetic cause of ALS.

“For more than a decade, Biogen has been steadfast in our commitment to pursuing treatments for ALS, and I want to thank the scientists as well as the entire ALS community who have all worked tirelessly to bring this first-of-its-kind treatment to people with SOD1-ALS.,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “Today also marks a pivotal moment in ALS research as we gained, for the first time, consensus that neurofilament can be used as a surrogate marker reasonably likely to predict clinical benefit in SOD1-ALS.”

Viehbacher says the company also believes this important scientific advancement will further accelerate innovative drug development for ALS.

Many families and individuals have been affected by this disorder. According to reports, there are approximately 330 people in the U.S. living with the disease.

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