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there's a difference between previous news of TauRx and recent news. Previous news before 2024 is without submission to regulatory bodies for marketing authorization. Recent news in 2nd half of 2024 is confirmed submission to UK MHRA for marketing authorization for UK market. That is a big difference in terms of progress. What's next - the decision from UK MHRA on whether to approve HMTM by TauRx for marketing authorization or reject it / conditional MA. Thereafter, NICE will review and make a decision on whether to approve HMTM for use in NHS; the public/gomen hospital if you will. Marketing authorization approval by UK MHRA means HMTM can be manufactured for sale in the UK.
will continue to share information (positive and negative) when I come across it, jiashen :) I am also learning about Genting by reading comments from other shareholders.
The UK’s National Institute for Health and Care Excellence (NICE) has issued further draft guidance reaffirming its decision not to recommend the Alzheimer’s treatments Kisunla (donanemab) and Leqembi (lecanemab) for use on the National Health Service (NHS) in England.
This is the second time NICE made a decision not to approve these treatments for NHS use. Leqembi, marketed by Biogen and Eisai, was first rejected for NHS coverage in August 2024, while a negative coverage decision for Eli Lilly’s Kisunla came in October 2024.
Following a request for additional evidence, NICE’s independent appraisal committee reviewed new data but maintained its stance that the medicines are not cost-effective. NICE stated that neither treatment provides sufficient benefit to justify the significant cost of provision and administration within the NHS.
The committee concluded that even under a managed access arrangement – where drugs are provided at a discounted price for a fixed period while additional evidence is collected – was not acceptable. “The cost-effectiveness estimates for donanemab and lecanemab remain substantially higher than we can consider an acceptable use of taxpayers’ money and NHS resources,” said NICE in the 6 March announcement.
The draft guidance has now been opened for public consultation, which will close on 27 March 2025, after which NICE will convene a third appraisal meeting to consider responses before issuing final recommendations. Kisunla and Leqembi are both monoclonal antibodies designed to slow early cognitive decline in Alzheimer’s patients by targeting amyloid beta plaques in the brain. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved both treatments in 2024, becoming the first regulatory agency to do so.
