Vials and packaging for Japanese drugmaker Eisai's medication Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease which has been approved by US health officials. Photo / AP
Vials and packaging for Japanese drugmaker Eisai's medication Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease which has been approved by US health officials. Photo / AP
Editorial
For those with Alzheimer’s disease and their carers, hope is massive.
The Associated Press reports US officials have granted full approval for a much-anticipated Alzheimer’s drug, clearing Medicare and other insurance plans to cover treatment for the debilitating brain disease.
The Food and Drug Administration endorsed the IV drug,Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease.
It’s the first medicine that’s been convincingly shown to modestly slow cognitive decline caused by Alzheimer’s.
Leqembi is intended for patients in the early stages, where clinical trials show it reduces protein build-up in the brain associated with memory loss, confusion and other symptoms.
Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.
The FDA has since reviewed data from a larger, 1800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those on a dummy drug.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” FDA’s neurology drug director Dr Teresa Buracchio said in a statement.
More than 50 million people worldwide suffer from Alzheimer's disease. Photo / Steven HWG, Unsplash
The new treatment isn’t without risk. The drug comes with the most serious type of warning of potential brain swelling and bleeding, side effects that can be dangerous in rare cases. However, these potential problems also exist with other plaque-targeting Alzheimer’s drugs.
This is huge news for many territories beyond the US, including New Zealand, where around 70,000 New Zealanders live with dementia - and that number is rapidly growing as the population ages.
Alzheimer’s drugs have shown promise in the past but failed to deliver on that potential. Tacrine was approved by the FDA in 1993. As with some following drugs, including Aricept, it was meant to slow the breakdown of acetylcholine, a neurotransmitter involved in memory and learning.
But the drug did not change the course of the disease and fell out of use due to liver toxicity concerns.
Plaque-targeting Alzheimer’s drugs such as Leqembi do not come with similar fears. Instead, there were concerns approval could overwhelm US Medicare’s finances, which provide care for 60 million seniors. Leqembi is priced at about $US26,500 for a year’s supply of IVs every two weeks.
Hospitals and medical clinics caution it may take time to get people started on the drug. Doctors need to confirm patients have the brain plaque that Leqembi targets before prescribing. Nurses need training to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. Imaging and administration services carry extra costs for hospitals beyond the drug itself.
For New Zealanders, access to the treatment will be some time away, and that’s only if Medsafe gives approval. Chief executive Catherine Hall told Newstalk ZB in December last year caution was still needed.
“There has been a huge amount of effort go into it over the last few decades, but so far, that has all ended in disappointment – promising drugs have not ended up having the impact that they were expected [to].”
