Biogen’s ASL Drug approved by FDA
New England Council member, Biogen, announced that the FDA has approved its drug for amyotrophic lateral sclerosis, or ALS.
A few months ago, Biogen submitted its new ASL drug, Tofersen, for consideration under the FDA’s accelerated approval pathway. This pathway allows the use of a surrogate endpoint that experts believe is reasonably likely to predict a clinical benefit, even if the benefit has yet to be proven in studies. With this, an advisory committee of experts voted unanimously in favor of accelerated approval for Tofersen and, on Tuesday, Biogen said the FDA had approved the drug. This new drug will be marketed under the name Qalsody and used to treat ALS patients with a mutation in the SOD1 gene.
“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 Chris Viehbacher, president and CEO 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. We believe this important scientific advancement will further accelerate innovative drug development for ALS.”
The New England Council commends Biogen for its commitment to the fight against ASL.
Read more from the Boston Business Journal.