The Food and Drug Administration granted the accelerated approval of a new drug that could help treat Alzheimer’s disease.
- The drug, called aducanumab, “can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments,” according to FDA.
- “Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit,” the FDA said.
Why are scientists worried about FDA’s approval?
The drug’s approval has drawn an interesting response across the board.
For starters, the drug had a weird track record — there was some research to show it was not better than a placebo drug — that led to an FDA advisory panel recommending against approval, according to Politico. But then, Alzheimer’s patient groups pushed the FDA to approve the drug because there are limited options. The FDA then decided to approve the drug.
- “This (accelerated approval) pathway allows FDA to provide patients suffering with a serious disease earlier access to a potentially valuable drug when there is some uncertainty of the clinical benefit of the drug,” Patrizia Cavazzoni, the FDA’s top drug regulator, told Politico.
However, experts remain concerned that the FDA could be influenced, and that its approval might not have as much as weight as before.
- “This signals a really bad step that’s going to diminish the integrity of FDA’s regulatory decisions and public confidence,” Joseph Ross, a physician at Yale University and co-director of the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation, told Politico. “It’s going to generate a lot of demand, which will lead to a lot of spending for a product which is unlikely to help people and may cause harm.”
Similarly, the Institute for Clinical and Economic Review released a draft of a report that suggested the drug cost $2,560 to $8,290 per year. And that the drug didn’t have perfect research behind it.
- According to CNN, the report said “the evidence is insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression”of Alzheimer’s disease.