Although there has been a deep division within its ranks, the Federal Drug Administration recently approved Aducanumab, the first new Alzheimer’s drug in nearly 20 years.
There was a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22 percent.
According to Kaiser Health News, some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.
“The Alzheimer’s Foundation of America (AFA) always holds out hope that new medications, if found to be safe, effective, and approved by the FDA, will become available to help the millions of families and individuals affected by Alzheimer’s disease,” the AFA stated.
“Today’s accelerated approval of Aducanumab by the FDA, the first new Alzheimer’s drug on the market in nearly two decades, provides hope as another important step in the fight against Alzheimer’s disease. We are hopeful that it will improve the quality of life for individuals living with Alzheimer’s disease and their caregivers. Patient access and affordability to all of those in need is of significant importance.
“Under the accelerated approval provisions, which provide patients earlier access to the treatment, the FDA is requiring a new randomized, controlled clinical trial to verify the drug’s clinical benefit,” the AFA said, noting that the organization was hopeful Aducanumab will improve the quality of life for disease sufferers and their caregivers. “If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”
A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company
“As I have said before, the devastating and costly effects of Alzheimer’s on those living with the disease and their loved ones are extremely difficult to deal with, and that pain is only compounded by the fact that there is still no effective treatment,” Rep. Maxine Waters (D-43), Chairwoman of the House Committee on Financial Services and Co-Chair of the Congressional Task Force on Alzheimer’s said in a statement.
“I expect that the FDA-ordered post-approval trial of the treatment will bring about more definitive information about Aducanumab’s effectiveness and I support the FDA’s ability to remove the drug from the market if necessary,” Waters said. “Alzheimer’s disease and related dementias have proven to be costly in many ways and as new treatments emerge, we must remain committed to removing barriers to them and ensuring that they are accessible to all people of all backgrounds who qualify for them.”