https://www.wsj.com/articles/biogen-fda-aduhelm-alzheimers-drug-approval-11641327408
For more than a decade, Biogen Inc. BIIB -1.02% worked on a new drug for Alzheimer’s disease that seemed to have blockbuster potential.
Early results were so impressive that Biogen raced toward regulatory approval—a risky gambit that drove up the stock as investors anticipated sales of the first approved drug in nearly two decades to slow the advancement of a disease affecting six million Americans.
Then Biogen changed its mind. The company made an unusual decision to abruptly stop its trials and declare that the drug didn’t work—then reversed course and said the drug did work after all.
The Food and Drug Administration approved the drug in June under a program that fast-tracks promising treatments, despite disagreements within the agency over its efficacy.
The result is a pricey therapy now on the market, Aduhelm, that regulators say isn’t fully proven to work against Alzheimer’s disease. Many patients aren’t taking it because doctors are reluctant to prescribe Aduhelm and Medicare hasn’t decided if it will pay for the drug.
Biogen launched Aduhelm in June at a price of $56,000 a year, only to backtrack in December and cut the price in half to quell backlash over the price. The company’s stock is trading at about half its 2021 high after the FDA approval.
In drug development, management mistakes can be as much of a factor as the complicated scientific questions. With Aduhelm, both played a role.
“All these inconsistencies created one wave of criticism after another—plus Biogen came up with this ridiculous price that added even more fuel to the fire,” said Yaning Wang, who as an FDA official worked on Aduhelm’s approval and is a supporter of the approval. He is now chief executive of a Chinese biotech company.
An FDA spokeswoman said the agency conducted a thorough review of Aduhelm’s data and concluded it warranted approval for patient use “while holding the company accountable for conducting an additional study” to confirm that the drug works. If the study fails, the FDA can pull Aduhelm from the market.
A Biogen spokeswoman said the company realized with hindsight that it made mistakes in stopping the trials early but that it did what it thought was right for patients at the time. Biogen CEO Michel Vounatsos in July told analysts: “Aduhelm was approved appropriately on very solid grounds and represented the right thing to do for patients.”
Some doctors say that they have encountered hesitancy among some patients to take the drug but that others are willing to try it. Aduhelm is “a risk that I would take,” said Michele Hall, a 54-year-old former lawyer who was diagnosed with Alzheimer’s in 2020 and started Aduhelm treatment in late December. She is willing to try the drug, hoping it will help slow her decline, even if only slightly, she said. “I’ll do whatever it takes to give myself more time.”
Other drugs help alleviate only some of the symptoms of Alzheimer’s. Researchers hope to show Aduhelm can slow the progressive brain deterioration that comes with Alzheimer’s, though it will be years before it can be definitively tested in a new clinical trial.
“Is Aduhelm great? No,” said Marwan Sabbagh, a neurologist at the Barrow Neurological Institute in Phoenix and a consultant for Biogen and other drugmakers. “It’s better than the status quo.”
Continued...
For more than a decade, Biogen Inc. BIIB -1.02% worked on a new drug for Alzheimer’s disease that seemed to have blockbuster potential.
Early results were so impressive that Biogen raced toward regulatory approval—a risky gambit that drove up the stock as investors anticipated sales of the first approved drug in nearly two decades to slow the advancement of a disease affecting six million Americans.
Then Biogen changed its mind. The company made an unusual decision to abruptly stop its trials and declare that the drug didn’t work—then reversed course and said the drug did work after all.
The Food and Drug Administration approved the drug in June under a program that fast-tracks promising treatments, despite disagreements within the agency over its efficacy.
The result is a pricey therapy now on the market, Aduhelm, that regulators say isn’t fully proven to work against Alzheimer’s disease. Many patients aren’t taking it because doctors are reluctant to prescribe Aduhelm and Medicare hasn’t decided if it will pay for the drug.
Biogen launched Aduhelm in June at a price of $56,000 a year, only to backtrack in December and cut the price in half to quell backlash over the price. The company’s stock is trading at about half its 2021 high after the FDA approval.
In drug development, management mistakes can be as much of a factor as the complicated scientific questions. With Aduhelm, both played a role.
“All these inconsistencies created one wave of criticism after another—plus Biogen came up with this ridiculous price that added even more fuel to the fire,” said Yaning Wang, who as an FDA official worked on Aduhelm’s approval and is a supporter of the approval. He is now chief executive of a Chinese biotech company.
An FDA spokeswoman said the agency conducted a thorough review of Aduhelm’s data and concluded it warranted approval for patient use “while holding the company accountable for conducting an additional study” to confirm that the drug works. If the study fails, the FDA can pull Aduhelm from the market.
A Biogen spokeswoman said the company realized with hindsight that it made mistakes in stopping the trials early but that it did what it thought was right for patients at the time. Biogen CEO Michel Vounatsos in July told analysts: “Aduhelm was approved appropriately on very solid grounds and represented the right thing to do for patients.”
Some doctors say that they have encountered hesitancy among some patients to take the drug but that others are willing to try it. Aduhelm is “a risk that I would take,” said Michele Hall, a 54-year-old former lawyer who was diagnosed with Alzheimer’s in 2020 and started Aduhelm treatment in late December. She is willing to try the drug, hoping it will help slow her decline, even if only slightly, she said. “I’ll do whatever it takes to give myself more time.”
Other drugs help alleviate only some of the symptoms of Alzheimer’s. Researchers hope to show Aduhelm can slow the progressive brain deterioration that comes with Alzheimer’s, though it will be years before it can be definitively tested in a new clinical trial.
“Is Aduhelm great? No,” said Marwan Sabbagh, a neurologist at the Barrow Neurological Institute in Phoenix and a consultant for Biogen and other drugmakers. “It’s better than the status quo.”
Continued...