A new drug that could halt the progress of early-stage Alzheimer’s Disease is being assessed by the US drug regulator, with hopes it could be approved for use as soon as next year.
If approved, the drug, aducanumab, could change the lives of millions of people around the world.
To date, no medication has been able to stop or slow the progress of dementia, and treatment has instead focused on easing symptoms of the condition.
But US pharmaceutical giant Biogen, says patients who received aducanumab experienced “significant benefits on measures of cognition and function such as memory, orientation, and language.
“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.
“If approved, 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,” Biogen said in a statement.
Decision to halt earlier trial overturned
In an unusual turn of events, Biogen halted an aducanumab trial earlier this year after results suggested the drug had no effect on clinical symptoms, such as memory loss.
But new data revealed higher doses of the medication given for a longer period significantly slowed cognitive decline. As a result, Biogen is now seeking US approval for the drug.
Professor Michael Woodward, director of aged care research at Austin Health, told HelloCare, “This is a really amazing result.
“It’s the first time a potentially disease modifying drug seems to be having a beneficial effect in those with Alzheimer’s. The first time ever.”
“It looked like the drug is actually having a positive result on cognition as well as reducing amyloid.”
“I’ve been doing this for 25-26 years, and I think we’ve finally turned a corner,” Proffessor Woodward told HelloCare.
“I think there’s a very good chance we’ll have our first drug that can essentially stop Alzheimer’s disease, not just treat the memory symptoms, but stop Alzheimer’s by removing the toxic amyloid protein.
“I think that what we’re going to be seeing is a proven therapy within a very short time.”
Drug removes toxic proteins
Professor Woodward explained that aducanumab acts by removing the protein amyloid from the brain.
“We know amyloid is the main protein that’s toxic to the brain that builds up in Alzheimer’s, so it would make sense that removing amyloid from the brain should be beneficial,” he said.
Could be worth $10 billion
Mr Woodward conceded that some “healthy scepticism” is warranted, but the results so far are “encouraging”.
The first drug to treat Alzheimer’s will probably be worth $10 billion, “so obviously people will do everything to try to come up with a positive result.”
“It’s encouraging that the FDA were shown the preliminary results and they said this is worth us having a look at. So there is an indication that even the independent assessor may come up with a positive outcome, which would be fantastic news,” Professor Woodward said.
Those in cancelled trial will go back onto the medication
The drug will now be made available to those who were in the initial trial that was cancelled.
“Those who have been told to stop it (aducanumab) because they initially thought the trial was futile, they will be offered to go back onto the drug. They’ll be going onto the drug and not onto the placebo. That’s going to happen very soon,” Professor Woodward said.
“There’ll probably be about 100-150 Australian on the drug by Christmas. It will be available, but only for those lucky enough to be in the trial.”
Once the FDA has approved the medication, Professor Woodward said doctors will then “theoretically” be able to access it here in Australia. But he warned the medication is likely to cost around $100,000 per year and there may only be limited supplied initially.
“So I wouldn’t be expecting it to be freely available in Australia for quite some time,” he said.
Professor Woodward warned that aducanumab is toxic.
“It causes brain swelling and brain micro bleeding in some people. That’s why you have to increase the dose very, very slowly.”
Put your hand up for trials
Professor Woodward said what has happened with aducanumab demonstrates why people should put their hand up for medication trials. Firstly because the data gained is useful, but also “you might be one of the lucky ones who get to go on a horribly expensive drug years before anyone else.”