报道称，NHS肯定会拒绝礼来的Donanemab。该报道还表示，鉴于该药物的副作用，MHRA甚至可能不会批准Donanemab上市。一位知情人士表示：“既然NICE已经拒绝了Leqembi，那么肯定不会批准Donanemab，因为Donanemab产生严重副作用的风险是Leqembi的两倍。”After the UK regulatory authority refused to approve BJ's Alzheimer's drug Leqembi for use in the UK National Health Service (NHS), there are reports that Eli Lilly's Alzheimer's drug Donanemab will face the same fate.
According to the Securities Times APP, after the UK regulatory authority refused to approve Biogen's (BIIB.US) Alzheimer's drug Leqembi for use in the UK National Health Service (NHS), there are reports that Eli Lilly (LLY.US) Alzheimer's drug Donanemab will face the same fate.
It is reported that on August 22, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved Leqembi for listing. However, at the same time, the UK healthcare regulatory institution responsible for deciding whether to provide drugs to NHS patients with government support - the National Institute for Health and Care Excellence (NICE) - stated in the guidance draft released last Friday that Leqembi will not be available on the NHS because its benefits are too small to justify its high cost.
The report stated that the NHS will definitely reject Eli Lilly's Donanemab. The report also stated that given the side effects of the drug, the MHRA may not even approve the launch of Donanemab. A source said: "Since NICE has already rejected Leqembi, it will definitely not approve Donanemab, because the risk of serious side effects from Donanemab is twice that of Leqembi."
Earlier in July, Donanemab received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic early-stage Alzheimer's disease under the brand name Kisunla. Eli Lilly priced Kisunla at $695.65 per vial. According to clinical trial data, 17% of patients reached the target within 6 months, 47% within 12 months, and 69% within 18 months. Based on this calculation, the cost for 6 months of treatment using 18 vials is $12,522, 12 months using 46 vials is $32,000, and 18 months using 70 vials is $48,696. In comparison, BJ's Leqembi is priced at $0.0265 million per year.
