The first approved drug in the EU to treat patients in the early stages of Alzheimer’s disease has been given the go ahead after more than two years of review.
The international community welcomed the decision by the European Commission to move forward with the approval of Leqembi (lecanemab) for the treatment of early Alzheimer’s disease.
This move has been described as a “pivotal moment” and “and landmark step forward”.
European Commission approval means it can be marketed in all EU countries but it must pass several hurdles in Ireland before it is made available by the HSE under drugs schemes.
The medicine is used to treat mild cognitive impairment in the early stages of Alzheimer’s disease, under strict conditions.
It is for use in people who have only one or no copy of the ApoE4 gene and who have amyloid beta plaques in the brain.
The Alzheimer Society of Ireland (ASI) said it is “heartened “by the potential for this treatment – the first disease modifying therapy for Alzheimer’s disease – to become available in Ireland, which will undeniably offer hope for many people and families affected by Alzheimer’s”.
A spokeswoman said that “this is a critical juncture for the future of dementia care, and it is essential that Ireland now prepares for the swift integration of Leqembi -and next generation of treatments in the clinical pipeline–into our healthcare system, ensuring that those who can avail of this treatment are able to access it as soon as possible”.
“While we are optimistic about the positive impact Leqembi will have, it is important to note that it is not a cure for Alzheimer’s Disease and will only be suitable for a small number of people in the early stages,” she added.
The authorisation allows the use of Leqembi to treat people with only one or no copy of the ApoE4 gene and who exhibit sticky clumps of a protein called amyloid beta in the brain, which is believed to be a hallmark of Alzheimer’s.
The decision to exclude those with two copies of the gene is the regulator leaning on the side of safety, said William Blair analyst at Myles Minter. He estimates over $900 million peak sales for the drug in the 2030s.
The decision is in line with that of the European Medicines Agency, which recently reiterated that Leqembi would be approved for a narrower set of patients than those in which it was tested.
While the regulator had backed Leqembi for patients with only one copy of the ApoE4 gene, the commission had requested another safety review.
Initially, the European medicines regulator had refused to back the drug’s approval due to serious safety risks.
Leqembi is approved in the United States for patients with two copies of the gene, but patients must undergo regular brain scans to monitor for any brain swelling.
Leqembi is also approved in Japan, China, the UK and several other markets.
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Source: Eilish O’Regan – Irish Independent
