In a highly controversial decision, the FDA gave accelerated approval to the first drug that could slow the progression of Alzheimer’s disease.
In a highly controversial decision, the FDA gave accelerated approval to the first drug that could slow the progression of Alzheimer’s disease. But the approval does not say the FDA thinks the drug actually will treat the disease. Rather, FDA carefully states that the drug, with the chemical name aducanumab and the brand name Aduhelm, reduces a substance on the brain that is associated with Alzheimer’s. In effect, FDA appears to have approved the drug, not because it is likely to successfully treat Alzheimer’s, but because it may lead to further research into other drugs that could. Such a rationale will benefit Biogen BIIB and could pave the way for important future progress, but its benefits for people who have dementia today are likely to be limited. Despite its questionable immediate value and Biogen’s plan to charge $56,000 annually for what it says are necessary infusions, desperate families are likely to demand the drug. It could not only put enormous pressure on doctors and family budgets, but it also could further strain the finances of Medicare. Unusual approval The drug’s path to approval was extremely unusual. Biogen did two clinical trials. One tentatively showed a 22 percent reduction in cognitive decline, which would have been an extraordinarily positive result. But the other found no benefit at all. After the second result, Biogen abandoned the research. Then it reopened its request for FDA approval, saying that giving high doses of the drug to people with very early stage disease could be beneficial. An independent FDA study panel strongly recommended the agency not approve t he drug, pending further research. In an unusual step, FDA rejected that recommendation and OK’d the drug. However, it required Biogen to stand up a third clinical trial to determine its effectiveness.
