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FDA gives fast-track approval to breakthrough Alzheimer’s drug
The US has granted fast-track approval to Lecanemab, a potentially ground-breaking new Alzheimer’s disease treatment. The drug - to be marketed in the US under the name Leqembi - was developed jointly by Japanese pharmaceutical company Eisai and US biotech firm Biogen. It takes the form of an engineered antibody that combats the build- up in the brain of beta amyloid protein – a key element in the progression of Alzheimer’s disease, the most common cause of dementia. Research evaluated by the FDA suggests that the use of Lecanemab leads to an observed reduction of amyloid beta plaque in the brains of patients with Alzheimer’s disease. Under its Accelerated Approval pathway,
the FDA may approve drugs for serious conditions where there is an unmet medical need and the treatment in question is likely to offer a clinical benefit to patients. According to Billy Dunn MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research: “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process
of Alzheimer’s, instead of only treating the symptoms of the disease.” It is hoped that approval from British and European regulators will follow suit. Eisai is understood to be readying an application for European authorisation via the European Medicines Agency (EMA) in March. It will then be for the EMA to decide whether to recommend that the European Commission approve Lecanemab.
In the UK, medicines are approved by the
MHRA (Medicines and Healthcare products Regulatory Agency). According to the government, post-Brexit, the MHRA will follow European Commission decisions on drug approvals until January 2024. Additionally, in order for Lecanemab to be offered by the NHS, it would have to be approved by NICE (the National Institute for Health and Care Excellence).
News
Skills for Care supports social care teams to #KeepLearning
Skills for Care has launched its ‘Keep learning for success’ campaign. The strategic workforce development and planning body for social care in England is encouraging social care managers and their teams to #KeepLearning by highlighting training and funding opportunities available for social care workers and focusing on the benefits that continual professional development brings for those working in social care and the people they support. The #KeepLearning campaign will run across Skills for Care’s website, social media, and other communications channels and will include resources to support with training, articles highlighting learning
and development opportunities, and real life insights from people working in social care. Skills for Care data shows that investing in learning and development is crucial for staff retention. Average turnover rates decreased from 41.2 per cent among staff who had no
training, to 31.7 per cent among those that received some form of training. Additionally, turnover was reduced by 9.1 per cent for care workers who received more than 30 instances of training when compared to care workers with one instance of training. Skills for Care CEO Oonagh Smyth said: “Our latest campaign aims to highlight to social care employers the range of different options and funding available to support them in providing ongoing development for their teams.
“This is vital not only in supporting a
good workplace culture and developing and keeping the people who work in care, but also in providing the best outcomes for people who draw on care and support.”
February 2023
www.thecarehomeenvironment.com
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