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The EU’s drug regulator has declined to approve a breakthrough Alzheimer’s treatment produced by drugmakers Eisai and Biogen, warning about rare brain swelling side-effects.
A European Medicines Agency committee on Friday recommended that Leqembi should be denied a marketing authorisation in the EU, severely knocking the likelihood of approval for use in the 27-member bloc. The neurodegenerative condition affects about 50mn people worldwide.
The move comes after the US Food and Drug Administration approved the drug for US patients last year. Thousands of Alzheimer’s patients have already received Leqembi infusions in the US, with the drug projected to generate $154mn in revenue worldwide this year, almost all from the US, according to analysts at Cantor Fitzgerald.
The EMA raised concerns about rare side-effects known as amyloid-related imaging abnormalities, or Aria, caused by the drug, noting that “some patients had serious events, including large bleeds in the brain which required hospitalisation”.
Leqembi, whose scientific name is lecanemab, is part of a new class of Alzheimer’s drugs that promise to slow the progression of the memory-robbing disease. Alzheimer’s diagnostics and treatments have become the focus of intense research efforts as knowledge of the condition’s causes improves.
Leqembi, similar to a rival drug from US pharmaceuticals group Eli Lilly, works by removing amyloid plaque which forms in knots on the brain in Alzheimer’s patients and is linked to progression of the disease.
But while the drug reduced cognitive decline by 27 per cent in early-stage Alzheimer’s patients compared with a placebo group in a late-stage clinical trial, it did also cause rare instances of brain swelling, which were sometimes fatal.
“The seriousness of this side-effect should be considered in the context of the small effect seen with the medicine,” the EMA added. “Overall, the [Committee for Medicinal Products for Human Use] considered that the benefits of treatment are not large enough to outweigh the risks associated with Leqembi.”
Japan’s Eisai said it planned to ask the EMA committee to re-examine its decision in a bid to win approval in the EU, where 6.9mn people suffer from Alzheimer’s. Alongside the US, Leqembi has been approved in five other countries including Japan and China.
Lynn Kramer, Eisai’s chief clinical officer, called the decision “extremely disappointing”, adding that “there is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression”.
John Hardy, a neuroscience professor at University College London, predicted that the EMA decision “will be revisited as US clinicians and others gather and report real-world experience”. About two-fifths of negative rulings by the EMA medicines committee are reversed, according to Jefferies analysts.
EU sales were expected to contribute as much as $1.6bn in peak annual sales for Leqembi, which is co-produced by Eisai with Boston-based biotech Biogen. Shares in Biogen were down 5.9 per cent in early trading on Friday.
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