Company seeks approval for first drug that could slow Alzheimer’s disease
Campaigners have welcomed steps towards approving a potentially “groundbreaking” drug treatment for people with Alzheimer’s.
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.
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.”
Alzheimer’s disease is the most common type of dementia, a condition that affects around 850,000 people living in the UK.
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 an 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.”
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