Sumary of Biogen shares surge 60% after FDA approves Alzheimer’s drug, the first new therapy for the disease in nearly two decades:
- The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s disease drug aducanumab, making it the first medication cleared by U.S..
- Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills..
- Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track aducanumab, but the road to regulatory approval has been a controversial one since it showed promise in 2016..
- Shares of Biogen soared in November after it won backing from FDA staff, who said the company showed highly “persuasive”.
- evidence aducanumab was effective and that it had “an acceptable safety profile that would support use in individuals with Alzheimer’s disease.”.
- When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”.
- Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials..
- Some doctors have said they won’t prescribe aducanumab if it does reach the market, because of the mixed data package supporting the company’s application….