On Friday, January 6, 2023, the FDA, the body responsible for regulating drugs in the United States, accepted the marketing of Lecanemab, under the trade name Leqembi. This molecule is developed by the Japanese laboratory Eisai, and marketed in collaboration with the American laboratory Biogen. Like Aducanumab before it, Lecanemab received early approval. This news brings new therapeutic hope for the millions of families affected by Alzheimer’s disease for which no cure is yet available.
What is Lecanemab?
Lecanemab is a monoclonal antibody directed against amyloid β protein (Aβ) which aims to reduce the number of amyloid plaques present in the brain as well as their accumulation. This mode of action is similar to that of Aducanumab, which we presented in a previous post. Which also obtained early marketing authorization in the United States in June 2021.
However, and unlike Aducanumab which presented controversial results. Lecanemab is one of the rare molecules for which positive results for a phase 3 study have been presented, on September 28th. With a proven clinical benefit translated by a 27% reduction in cognitive decline in people affected by Alzheimer’s disease at a mild stage (for more information on this subject: article).
Other data, not yet published but presented at the CTAD (Clinical Trial Alzheimer Disease) congress in November 2022, also present very interesting results. In particular on the well-being of people with Alzheimer’s disease and their caregivers resulting in an improvement in their quality of life.
“Alzheimer’s disease has a huge impact on the lives of those suffering from this disease and has devastating effects on their loved ones. This treatment is the latest therapy that targets and affects the processes underlying Alzheimer’s disease. Instead of treating only the symptoms of the disease” specifies Billy Dunn, director of the office Neurosciences of the FDA.
Who is the treatment for?
Treatment will be available in the United States for people with mild cognitive impairment or mild Alzheimer’s disease, corresponding to the stages of the patients who participated in the study. There are currently no data on the effectiveness or safety of using the drug in early or late stages of Alzheimer’s disease.
Lecanemab can cause microhemorrhages in the brain, called ARIA, which are most often asymptomatic but can be dangerous and disabling. This possibility obliges healthcare professionals, as with Aducanumab, to carry out regular checks of the progress of the treatment by imaging.
After the anticipated US marketing authorization, Aducanumab had raised a lot of controversy because of its high cost of its drug. Initially offered at $56,000 per year, then at $28,200 six months later, the drug is expensive and requires regular follow-ups, which further increases the total cost of care.
Regarding the drug Leqembi, the Eisai laboratory proposed and justified a price amounting to $26,500 per year. He hopes to lower that price by reducing the doses needed to maintain the drug’s beneficial effects, but that requires more scientific data. He also hopes to be able to benefit, in view of the results obtained, from coverage by American insurance, which could drastically reduce the rest payable by patients.
The next steps
The Eisai laboratory has already claimed to have filed a classic marketing application for the American territory. This should make access to treatment simpler and make it easier to cover all or part of the medical costs. For the rest of the world, Eisai has already initiated the submission of the file to the National Medical Products Administration (NMPA) which deals with authorizations in China in December 2022. Applications for Japan and Europe are expected to be submitted before the end of March 2023.
Finally, Eisai has not finished the development of its drugs since several studies have already been announced to continue the development of Lecanemab by modifying in particular its method of administration.
The France Alzheimer and related diseases association welcomes this news with enthusiasm. The possibility of a new effective drug is a therapeutic hope for the families we support. However, we still have to wait for its use on French soil. Even if Lecanemab, or rather Leqembi in its marketed form, is not a miracle cure. This may be a first step towards stabilizing the disease in millions of people affected by Alzheimer’s disease.
We are now awaiting the decision of the European Medicines Agency (EMA) at the end of March. As a reminder, it refused Biogen’s request for Aducanumab based on the absence of proven clinical benefits.
#drug #Lecanemab #authorized #American #market