2024-08-05 22:32:32
Recembi, red light for approval in Europe
AbbVie halts development of dementia drug
Dementia (Alzheimer’s), a disease known as ‘impregnable’, is still having difficulty passing the approval threshold despite the development of treatments. Some companies that were researching dementia treatments are even stopping or giving up on development.
According to industry sources and foreign media outlets such as the BBC on the 5th, the Alzheimer’s treatment drug ‘Rekemvi’ (ingredient name: recanemab), which has been approved in the US and Korea, is at risk of not being approved in Europe.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently refused to approve recanemab, an Alzheimer’s treatment that slows cognitive decline.
It was concluded that although cognitive decline was delayed in patients administered recanemab, the effect was minimal. It also cited the issue of side effects and concluded that the treatment benefits were not sufficient to outweigh the risks.
Recanemab has been confirmed to be safe and effective in treating patients with mild cognitive impairment or mild Alzheimer’s disease due to Alzheimer’s disease. It reduces brain amyloid deposits, known as a strong cause of Alzheimer’s disease, and slows the progression of the disease, including cognitive function loss. However, its efficacy and safety have not been confirmed for patients with moderate or more advanced Alzheimer’s disease.
Recanemab also caused side effects of amyloid-related imaging abnormalities (ARIA), which involve brain swelling and bleeding. Most were not serious, but some patients had bleeding in the brain large enough to require hospitalization.
Recently, there has been a series of news reports of global companies discontinuing development of Alzheimer’s treatment drugs.
AbbVie recently announced that it is discontinuing the development of its Alzheimer’s treatment ‘ABBV-916’, which was in phase 2 clinical trials.
“We recently completed an interim analysis of the Phase 2 study evaluating ABBV-916,” said Dr. Roopal Thakkar, AbbVie’s executive vice president of R&D and chief scientific officer, during the company’s quarterly earnings call on the 25th of last month. “While the efficacy and safety profile are similar to those demonstrated with approved agents, given the evolving landscape, we do not believe it is sufficiently differentiated from other therapies for use as a monotherapy, and so we are discontinuing development.”
ABBV-916 is designed to remove amyloid plaques that accumulate in the brain and cause problems for nerve cells sending and receiving signals. It has the same specificity as Eli Lilly’s dementia treatment ‘donanemab’, which was recently approved by the U.S. Food and Drug Administration (FDA).
Japan’s Otsuka Pharmaceutical announced in May that it would discontinue the development of ‘AVP-786’, a treatment for agitation in Alzheimer’s patients, and global pharmaceutical company Roche also discontinued the development of its Alzheimer’s treatment ‘gantenerumab’ last year after failing in phase 3 clinical trials.
The Alzheimer’s treatment drug ‘Aduhelm’ (aducadumab) developed by the American company Biogen received conditional approval from the FDA through the fast track system, but development and sales were halted in February of this year due to controversy over its efficacy. This is because the medical community was reluctant to prescribe Aduhelm and it failed to be listed on insurance, resulting in poor performance.
In this way, Alzheimer’s treatment is difficult to develop, and even if it is developed, it is difficult to get approval and commercialization. However, experts say that even if a new treatment does not show outstanding effects, it should be considered a new turning point in treatment and should be used.
Professor Tara Spires-Jones, president of the British Neuroscience Association, said the failure to approve recanemab in Europe “will be disappointing to many patients” and “we must step up our efforts to find new and safer treatments.”
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2024-08-05 22:32:32