Biogen seeks FDA OK for Alzheimer's drug

A US drug company says it has created the first drug to slow Alzheimer's disease and will seek regulatory approval in 2020 to sell it.

Biogen, a Cambridge, Massachusetts-based company, said its drug aducanumab could slow the effects of early onset Alzheimer's, limiting severe memory loss.

The drugmaker will seek approval from the Federal Drug Administration (FDA) next year to bring it to market. Approval could take a year to two years. Biogen also wants to sell the drug in parts of Europe.

"This could be a game-changer,'' said an executive with the Alzheimer's Association. "We are very hopeful."

Biogen CEO Michel Vounatsos said he is "reasonably confident" the FDA will approve the drug.

"We worked in full transparency with the regulator," Vounatsos told CNBC. "The evidence came over time. We collected a tremendous and complex set of data, including biomarkers and imaging. … I'm reasonably confident this will lead to market approval one day."

The announcement that Biogen would push ahead with aducanumab was a surprise to the scientific industry, as the company had said it would discontinue trials of the drug in March 2019 following disappointing results.

Biogen said it reconsidered the drug after analysis of a larger data set showed that aducanumab "reduced clinical decline in patients with early Alzheimer's disease". It also allowed patients to "experience significant benefits on …functions such as memory, orientation, and language."

The drug works by targeting a protein called beta-amyloid that forms abnormal deposits in the brains of those with Alzheimer's, according to the BBC.

By clearing the deposits, which scientists say are toxic to the brain, it's believed that it significantly helps people with dementia and Alzheimer's.

More than 5.8 million Americans live with Alzheimer's, according to the Alzheimer's Association. It is the country's sixth leading cause of death among those age 65 and over.

Dr Rebecca Edelmayer, director of Scientific Engagement at the Alzheimer's Association, the leading voluntary health organization in Alzheimer's care, support and research in the US, told China Daily:

"The Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for aducanumab. ... From what we've learned from research so far, targeting amyloid only will not be a 'magic bullet', and this drug is not the cure. That said, this drug, if approved, may open the window to more advanced therapies and combination therapies.

"A thorough examination of all the findings will be needed before any decision can be made on the drug's approval. This is a very important moment for the Alzheimer's field — for the first time in a long time, new treatment data is being submitted to the FDA for review. This could be a game-changer. We are very hopeful."

Alzheimer's is the most common type of dementia (accounting for 60 to 80 percent of cases). It mainly affects people's memory and cognitive abilities. There is no cure. Those aged 65 and older are at particular risk.

Around 200,000 people below age 65 have the disease. The number of Americans who will get the progressive brain disease is forecast to increase to 14 million by 2050.

The number of people affected by dementia worldwide is 50 million, according to the World Health Organization. Alzheimer's affects 850,000 people in the UK and 9.5 million in China. More than 100 million worldwide could be affected by Alzheimer's by 2050.

In the US, Alzheimer's care is a $250 billion industry. Research into the degenerative disease is also big business. The 2018 US federal budget granted $1.8 billion to Alzheimer's and dementia research. Congress set aside an additional $414 million.

Hunter K. Anstine, chief development officer for the Alzheimer's Research Foundation, told China Daily: "There's over 200 forms of dementia, and Alzheimer's is just a piece of that. We get hung up on talking about Alzheimer's all the time when the bigger villain in all of this is dementia. The progress we're making in terms of treatment and hopefully funding a cure is real. ... A cure is possible.

"The problem with dementia is usually it's your mom or dad, and they start to forget who you are. They might not be able to recognize their son or daughter for years. And your mom or dad are standing right in front of you. You're looking at them and you love them. They're looking at you and don't know who you are. That is heartbreaking."