Cantor Fitzgerald senior biotech analyst Alethia Young joins 'Closing Bell' to discuss the FDA approval for Biogen's Alzheimer's drug, calling this "one of the biggest approvals in biotech's history." For access to live and exclusive video from CNBC subscribe to CNBC PRO: [ Ссылка ]
The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s disease drug aducanumab, making it the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.
The FDA’s decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company and offers new hope to friends and families of patients living with the disease.
Biogen’s stock was halted for the announcement. The shares later resumed trading, surging more than 60% at one point, before paring that gain and closing up 38% at $395.85.
“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.
The FDA said it will continue to monitor the drug as it reaches the U.S. market. The agency granted approval on the condition that Biogen conduct another clinical trial. The Massachusetts-based biotechnology company said Monday that aducanumab’s list price is $56,000 per year; $4,312 per infusion.
Biogen CEO Michel Vounatsos told CNBC’s “Power Lunch” later Monday that he thought the drug’s price was “fair” but also vowed that the company would not hike its price for four years.
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