Health regulators are being urged to rapidly approve two gamechanging dementia drugs to ensure millions of people who could benefit are not "left in limbo". The final results from a landmark study confirmed that donanemab, made by Eli Lilly, slowed cognitive decline in Alzheimer's patients by 35%.
Trial results published last year showed that a second drug, lecanemab, made by Eisai and Biogen, reduced the rate by 27%.
Health leaders hailed the arrival of the drugs as a "turning point in the fight against Alzheimer's", through which the disease could become just as manageable as conditions such as diabetes or asthma. Dr Susan Kohlhaas, the executive director of research and partnerships at Alzheimer's Research UK, told the Guardian it was critical for regulators to act promptly to avoid patients experiencing waits for clinically effective treatments.
"We now have two potentially life-changing Alzheimer's treatments on the horizon and we need to see rapid regulatory decisions so people who could benefit from these treatments aren't left in limbo," Kohlhaas said.
"After 20 years without new Alzheimer's medicines, people affected by this disease deserve to have answers about new treatments as quickly as possible."
Eli Lilly has applied for approval for donanemab in the US and will do so in the UK within weeks, according to a person familiar with the matter. "Submissions to other global regulators are under way," they added.
Lecanemab received approval in the US this month but it is still waiting for a decision from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. It is also awaiting approval in Australia.
Diese Geschichte stammt aus der July 18, 2023-Ausgabe von The Guardian.
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