New analysis finds Alzheimer’s treatment may work

PROVIDENCE – In a surprise but welcome development, pharmaceutical firm Biogen and Japanese partner Eisai on Tuesday announced they will seek federal approval for aducanumab, a drug aimed at reducing cognitive decline in people living with Alzheimer’s disease. Local researchers immediately hailed the unexpected decision.

The companies in March abruptly stopped clinical trials of the drug, which removes amyloid-beta plaque formations in the brain associated with Alzheimer’s, when a so-called “futility analysis” suggested it was ineffective.

But study of new and larger data recently led Eisai and Cambridge-based Biogen to seek approval from the federal Food and Drug Administration for use with “eligible patients previously enrolled in clinical studies,” the firms said in a joint statement. Success in this new phase could lead to approval for the general market.

“Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language,” according to Tuesday’s announcement. “Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.”

Dr. Stephen P. Salloway, director of Butler Hospital’s Memory and Aging Program, which conducted clinical trials of the drug, said the March decision “was a crushing blow to researchers and study participants around the nation, including the 60 trial participants here at the Memory and Aging Program. Many of our patients had seemed to be benefiting from the drug.”

Tuesday’s announcement, he said, was “very exciting news for our patients. Rhode Islanders who participated in the original study made a huge contribution to the success of this trial and their courage and dedication is very inspiring.”

Dr. Brian R. Ott, director of The Rhode Island Hospital Alzheimer’s Disease and Memory Disorders Center, which has been involved in testing of aducanumab since 2013, told the Journal that approval of the drug would be a “real game-changer for how we approach this widespread, progressive and fatal disease.”

He added: “This announcement provides very promising news that our efforts and those of all the patient and family volunteers for this program over all these years have paid off. We are very much looking forward to hearing the outcome of the FDA’s review of Biogen’s application for market approval of aducanumab in the coming year.”

“If approved,” the companies said, “aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.”