- USA approves first new drug in 20 years
- The drug reduces levels of sticky plaque in the brain
- Approved studies into the drug continue
In a significant world-wide event, the US health regulator has approved a new drug to treat Alzheimer’s disease. It is the first time since 2003 this has happened.
Health and aged care newsletter, HelloCare, reports the decision has caused controversy.
The drug, which is called Aducanumab but will be marketed as Aduhelm, has been shown to reduce levels of beta-amyloid, the sticky plaque that is the hallmark of Alzheimer’s disease, in the brain.
HelloCare says the studies have not been able to show the drug slows declines in memory and thinking, and in fact, "two large recent studies have had opposite findings.”
In November, a panel of the US Food and Drug Administration (FDA) advisers recommended the agency not approve the drug.
The FDA approved the drug through its ‘accelerated approval pathway’, a fast-track approval process designed to hasten access to drugs that could provide a “meaningful therapeutic advantage” over existing treatments for patients with serious or life-threatening diseases, and where a clinical benefit is “expected” – even if there is still uncertainty about the benefit.
A condition of the approval is that Biogen, the company that makes the drug, conducts further research to confirm the reduction of amyloid plaques does in fact cause clinical improvements for patients.
These studies could take several years, and if they fail to show Aducanumab causes an improvement, the approval may be withdrawn. In the meantime, Aducanumab will be available for sale in the United States.
Some have voiced concerns Biogen may have trouble recruiting enough people to take part in the trial, because with the drug now available, potential participants may not want to risk getting the placebo.
The drug will be administered through monthly infusions. Anyone taking the drug will need to have regular brain scans in order to detect a rare side effect: bleeding or swelling in the brain.
In a media release marking the approval, Dementia Australia said the approval was “exciting news” for the global dementia community.
Dementia Australia Honorary Medical Advisor Associate Professor Michael Woodward AM is quoted as saying that the new drug may have benefits when administered at the right time and at the right dose.
“When researchers examined more data that included more people who had been, for longer periods, on the highest dose they demonstrated a significant effect.
He went on to say, “Aducanumab should only be used in the early stages of dementia and may not work for everyone. It can also cause side effects and these need to be carefully monitored with regular MRIs."
“It is possible that, if used very early in Alzheimer's disease, this drug will prevent the emergence of the symptoms of Alzheimer's, but there is still research to be done in this area.”
Professor Woodward added that though there is no cure for Alzheimer’s disease, a drug that can remove the amyloid proteins is a significant step forward.
The drug is currently under review by Australia’s Therapeutic Goods Administration (TGA), with a decision expected in early 2022.
Source: Hello Care