This submission is the first “filing for FDA approval of a treatment that addresses the clinical decline associated with the devastating condition,” said Biogen, adding that the company is also seeking priority review which if granted could see a final decision on the drug by March of 2021; and the application contained over 4,500 files and close to 2.5 million pages.
“Alzheimer’s disease remains one of the greatest public health challenges of our time,” Michael Vounatsos, Biogen chief executive officer, said in a press release. “It robs memories, independence and eventually the ability to perform basic tasks from the people we love.”
Haruo Naito, Eisai chief executive officer, called the FDA application an “important step” in fighting Alzheimer’s, one which, he added, “currently cannot be stopped, delayed or prevented.”
Aducanumab is a somewhat controversial test drug having had a rocky history, with early stage trials showing a lot of success in clearing amyloid plaque from the brains of those affected, but the trial was abruptly cancelled in early 2019 siting a failure to pass a “futility analysis” which means that it was successful in clearing amyloid but it did not led to any significant changes in slowing the progression of disease.
However, in October 2019 late arriving data showed improvement in those living with mild cognitive impairment or very early stage Alzheimer’s disease; and in December 2019 an announcement was made saying those receiving the drug experienced significant slowing of decline in measures of cognition and functions such as memory, orientation and language. According to the announcement patients also experience a slowing decline in carrying out daily activities such as conducting personal finances, independent out of home travel, and performing household chores.
“For many people living with the early stages of Alzheimer’s disease, maintaining independence for as long as possible is the ultimate goal,” said Stephen Salloway, director of the Butler Hospital Memory and Aging Program at Brown University.
“If we can help slow the progression from one stage to the next,” Salloway said in the Biogen release, “this could preserve independence, which, in turn, could have truly meaningful benefits for people living with the disease and their loved ones.”
The application was welcomed by the Alzheimer’s Association: “For the first time in more than a decade, a new treatment for cognitive decline related to Alzheimer’s has been submitted to the FDA for review,” said Maria C. Carrillo, the Association’s chief medical officer, who is looking forward to the next step if the drug gains approval, and if it does Carrillo says, “the top priority for the Alzheimer’s Association is to ensure access to the drug — as soon as possible — for everyone that could benefit.”
