The FDA is taking a controversial step to approve the treatment even before there is proof that it works, granting approval to the drug Aducanumab. Made by pharmaceutical company Biogen, it attacks the amyloid protein, a type of plaque that builds up in the brains of Alzheimer’s patients.
Biogen CEO Michel Vounatsos said, “After almost two decades without any innovation, it is a new day. it is some hope finally for the patients and families.”
The Alzheimer’s Association is calling the approval a victory. The association’s chief science officer, Maria Carilla, said, “This is the first FDA drug approval in our history that delays the decline due to Alzheimer’s disease and that’s amazing.”
But the approval is controversial. The FDA is requiring Biogen to conduct another trial even though the drug will be on the market because the agency says there are “uncertainties regarding clinical benefit.”
Biogen does not contest the need for more research, adding they are committed to continuing studying the product.
Dr. Jason Karlawish with Penn Memory Center said, “The FDA is using a special regulatory mechanism called accelerated approval which allows a drug to be put out with evidence that is tentative.”
The FDA’s own independent advisory committee urged the agency to reject the drug, warning the evidence does not show that the drug slows Alzheimer’s and that there are serious side effects including swelling and even bleeding inside the brain.
But Phil Gutis took part in the trial. He’s been taking Aducanumab for five years and says it has worked for him. “If there’s a possibility that this drug can slow down the progression of this disease and give people more time with their families, maybe more time working, more time just living, and being part of society, then why wouldn’t you want to approve it?” he said.
It will come with a steep price tag. Each IV infusion costs $4,300, a year of treatment is $56,000. It’s a lot of money, some critics say, for a drug that still needs to prove it works.
Some experts worry it may slow down research while others argue an approval like this one is exactly what is needed to inspire new breakthroughs in the field.