now, a new Alzheimer's drug could be approved, on the level as the first active ingredient to the cause of the disease. On Thursday, Samantha presented to Budd by the U.S. pharmaceutical company Biogen an audience of specialists at the Alzheimer's disease conference (CTAD) in San Diego data from two large patient studies. The detailed analysis of the study results was long-awaited.
The two studies, each with approximately 1600 patients had made this year's headlines. They were stopped in March, because the substance, an antibody called Aducanumab seemed not to work. Then, Biogen announced that together with its Japanese Partner Eisai in October, in a re-analysis and further data, but an effect was found.
Now, independent experts were able to make yourself a picture and we are impressed. It was the first positive result of a drug against Alzheimer's disease for years, said the canadian Doctor Sharon Cohen. The were "very important results", was the neurologist Paul Aisen from San Diego. "I believe that the substance is," says Lutz Frölich Central Institute of Mental health in Mannheim, Germany. It has been convinced by the results, according to which it is clearly indicated that the effects are dose-dependent. That is, The patients in the study, the longest of the active substance in the highest dose, were the best.
changes in the brain
Add to that a small group of about 30 study participants was more closely examined. Imaging techniques showed in the brains of the Affected, that is exactly the went ill deposits in the brain are liable to return, to which the antibody attaches. Specifically, this means: In patients in an early stage of Alzheimer's disease, the progressive, developed at the end of Forget, thanks to Aducanumab slower than in the control group.
Also, the Biogen drug could stop Alzheimer's disease or missing mental skills to bring back. Nevertheless, If the Affected can work a year longer or your car independently, it was already a great success, says Sharon Cohen.
Biogen and Eisai had already announced in October, to apply for an authorisation for the active ingredient Aducanumab in the United States. If the competent authority, the FDA considers the data as sufficiently, could show up in a few months.
The other approach will probably look like that in the US study centers those patients who wish to re-Aducanumab be obtained. The Physicians in charge would collect additional data, which could later also be submitted to the approval authority. Frölich stresses that must prove the substance if it is allowed in practice. Then it will show whether Aducanumab works better than existing drugs. The side effects such as Nausea or headaches need to be followed.
it is Conceivable that a combination of the available drugs used for Alzheimer's therapy. And, of course, will also be the question of the cost. Frölich estimates that a new active ingredient that is administered once monthly as an Infusion, many times could be more expensive than treatment with the previously available resources.
Created: 09.12.2019, 09:11 PM