Campaigners have welcomed steps towards approving a potentially ‘groundbreaking’ drug treatment for people with Alzheimer’s. The drug maker, Biogen, said it was seeking regulatory approval for aducanumab in the US on Tuesday after new analysis of drug trial data revealed it had helped reduce the clinical decline of patients with early Alzheimer’s disease. This will be the first treatment to help slow Alzheimer’s disease and could soon be available to millions. Biogen said some patients had experienced benefits in the areas of memory, orientation, language and everyday living skills such as shopping and doing laundry.
In a statement Biogen said: “If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease.”
Reacting to the company’s announcement, Hilary Evans, chief executive at Alzheimer’s Research UK, said: “People affected by Alzheimer’s have waited a long time for a life-changing new treatment and this exciting announcement offers new hope that one could be in sight.”
Dementia causes an ongoing decline in brain function, which can affect memory, thinking speed, speech, mood and movement.
The decision to seek regulatory approval of aducanumab follows clinical studies being discontinued in March this year.
In an update to investors, Biogen said the findings of an initial analysis were “incorrect” with an examination of a larger dataset showing aducanumab reduced clinical decline in patients in the early stages of Alzheimer’s.
The company said the positive results of the new analysis were driven by patients having a greater exposure to a high dose of aducanumab, a drug designed to help the body clear harmful plaques from the brain.
Ms Evans said: “Taking another look at aducanumab is a positive step for all those who took part in the clinical trials and the worldwide dementia research community.
As more data emerges, we hope it will spark global discussions about the next steps for delivering much-needed treatments into people’s hands.”
Biogen said it would submit a licence application for aducanumab in the US in early 2020. It said it was continuing to speak to regulatory authorities in other markets, including Europe.
Michel Vounatsos, chief executive officer at Biogen, said: “With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s.
“This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients.”
Crucially, the company said trial data for drug aducanumab is strong enough to apply for medicine licences in the US, Europe and Japan early next year.
Despite billions of pounds spent on research, no company has got to the point of submitting an application to drugs regulators before.
CEO Michel Vounatsos said the company had already received encouragement from US regulator the Food and Drugs Administration.
“We got clear support from the FDA,” he said. “With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s.”