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By Shubhangi Mathur 4:38 pm ET
Food and DrugAdministration(FDA) approved Alzheimer’s disease drug aducanumab by Biogen—the firstdrug approved by US regulators which slows cognitive decline in peoplesuffering with the disease.
TheAlzheimer’s drug, named Aduhelm, is expected to earn the company billions ofdollars as revenue. The stock of the company was trading at 60 per cent at onepoint on Monday.
“We are well-aware of the attention surrounding thisapproval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for DrugEvaluation and Research, said in a press release. “We understand that Aduhelmhas garnered the attention of the press, the Alzheimer’s patient community, ourelected officials, and other interested stakeholders.”
“With a treatment for a serious, life-threatening disease inthe balance, it makes sense that so many people were following the outcome ofthis review,” Cavazzoni added.
FDA hassaid that it will also monitor the drug, which is the first new medicinefor the disease in nearly two decades, once it reaches the US market. FDA hasapproved the drug on the condition that the company will conduct anotherclinical trial.
“It is a new day,” Harry Johns, CEO of the Alzheimer’sAssociation, said in a statement. “This approval allows people living withAlzheimer’s more time to live better. For families it means being able to holdon to their loved ones longer. It is about reinvigorating scientists andcompanies in the fight against this scourge of a disease. It is about hope.”
No drugs have been cleared by FDA until now which helps inslowing the mental decline from the disease which is the sixth-leading cause ofdeath in US. FDA has also clarified that the drug it aimed at helping symptoms,not slowing the disease itself.
The drug by Biogen targets a “sticky” compound in the brainknown as beta-amyloid, which scientists expect plays a role in the devastatingdisease.
On Monday, FDA said it has found “substantial evidence”which proves that the drug helps patients. “As a result of FDA’s approval ofAduhelm, patients with Alzheimer’s disease have an important and critical newtreatment to help combat this disease,” it said.
(Withinputs from CNBC)