FDA has approved the Aduhelm (aducanumab) from Biogen, the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.
The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase.
It remains to be seen, however, just how big of a blockbuster Aduhelm will be. Some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective. Last November, an FDA advisory committee also expressed reservations about aducanumab’s clinical trial data. Three of those members explained their reasoning in a March editorial in JAMA.
But optimists stress that Aduhelm’s approval could also mark a turning point in treating Alzheimer’s disease (AD). “Aduhelm is the first therapy to target and affect the underlying disease process of AD,” said Alessio Brunello, managing analyst at GlobalData. “Currently, the available therapies only treat symptoms of the disease, whereas this drug actually works to clear amyloid plaques in the brain.”
Still, Brunello notes that aducanumab, as infusion therapy, could pose hurdles for some patients. “Additionally, concerns regarding the development of amyloid-related imaging abnormalities (ARIAs) represent a barrier for the uptake for Aduhelm,” he added. “Physicians will also be obliged to do regular MRIs on patients to see if they have ARIA reactions, which could be a limitation, as repeated MRIs represent an additional economic burden.”
Most significantly is the drug’s price tag of approximately $50,000 annually, which may limit support from payers.
GlobalData nevertheless projects aducanumab will rake in $5.5 billion internationally by 2027.
The approval could also embolden FDA critics, such as the progressive advocacy group Public Citizen, which has accused FDA’s Office of Neuroscience of prioritizing the pharma industry over patients.
Already, the independent nonprofit Institute for Clinical and Economic Review (ICER) released a statement saying FDA, in its decision to approve aducanumab, has “failed in its responsibility to protect patients and families from unproven treatments with known harms.”