FDA approves Biogen’s Alzheimer drug; company’s shares surge

Food and Drug Administration approved Alzheimer’s disease drug aducanumab by Biogen—the first drug approved by US regulators which slows cognitive decline in people suffering with the disease.

The Alzheimer’s drug, named Aduhelm, is expected to earn the company billions of dollars as revenue. The stock of the company was trading at 60 per cent at one point on Monday.

“We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.”

“With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review,” Cavazzoni added.

FDA has said that it will also monitor the drug, which is the first new medicine for the disease in nearly two decades, once it reaches the US market. FDA has approved the drug on the condition that the company will conduct another clinical trial.

“It is a new day,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement. “This approval allows people living with Alzheimer’s more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”

No drugs have been cleared by FDA until now which helps in slowing the mental decline from the disease which is the sixth-leading cause of death 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 brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

On Monday, FDA said it has found “substantial evidence” which proves that the drug helps patients. “As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease,” it said.

(With inputs from CNBC)

Picture Credits: CNBC