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Known to many as Lou Gehrig s disease, ALS or amyotrophic lateral sclerosis has presented a major challenge for drug developers. Like many diseases of the brain, the complicated biology behind ALS has resulted in new, promising therapies failing time and again.
Among the few experimental drugs that have made it to the final stages of human testing is tofersen. Developed by Ionis Pharmaceuticals and Biogen, tofersen is meant for a very small subset of patients with certain genetic abnormalities that can cause ALS. Specifically, the drug is supposed to stop these patients from producing a protein called SOD1, which, when mutated, can give rise to the disease.
Permission granted by Biogen
A make-or-break moment is quickly approaching for what some consider the world s most closely watched experimental medicine. By June 7, the Food and Drug Administration should decide whether to approve or reject aducanumab, a potentially first-of-its-kind therapy meant to slow the progression of Alzheimer s disease.
The FDA s verdict is far from certain. The data supporting aducanumab are complex and controversial. Alzheimer s experts remain torn on whether the drug actually improves patients lives. Even the FDA s internal staff are divided about the prospect of approval.
However the agency ultimately leans, its decision will have significant impacts on both Alzheimer s care as well as aducanumab s developers, Biogen and Eisai.
Operator
Good morning. My name is Ashley, and I ll be your conference operator today. At this time, I would like to welcome everyone to the Biogen s First Quarter Earnings Call and Financial Updates. All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question-and-answer session. [Operator Instructions]
Thank you. I would now like to turn the conference over to Mr. Mike Hencke, Director, Investor Relations. Mr. Hencke, you may begin your conference.
Mike Hencke
Director of Investor Relations
Good morning, and welcome to Biogen s first quarter 2021 earnings call. Before we begin, I encourage everyone to go to the Investors section of biogen.com to find the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today.
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Amylyx Pharmaceuticals has developed a drug that could slow the fatal neurological disease ALS.
It s set to seek approval this year in Canada and Europe, but the FDA has asked for another trial.
That means people with ALS in the US will have to wait to get access to the promising treatment.
In the four years since Corey Polen was diagnosed with the neurological disease amyotrophic lateral sclerosis, or ALS, the disease has stolen his ability to type with his hands and attacked his vocal cords.