There is hardly a drug, the expected humanity to you again as a means not to Forget. Around 50 million people worldwide with Alzheimer’s disease or another Form of dementia lives. You know what it means when memories fade. Only the new one. Then the old, while the disease digs further and further in the personality.
For decades, many companies fail to not bring an agent to the market, which relieves for a short time only symptoms, but in fact, the progression of the disease slows down. That could change now. The company has announced Biogen, to apply for next year in the U.S. a marketing authorisation for the anti-body Aducanumab. It would be the first application for an Alzheimer’s therapy since the age of 16. However, the agent is highly controversial.
In March, Biogen had announced that the anti-body acting. Since 2015, the company had tried, the effects of the Agent in two studies to prove it. But the results seemed so hopeless, that Biogen was interrupted in both studies. Nevertheless, the company evaluated in the coming months patient data, the results of which were incorporated in the interim results.
At the end of October, the big Surprise was followed by: Biogen its investors informed, the medicine act, at least high-dose and in some patients in a very early stage of the disease. It’s a lot of money, Wall Street analysts estimate that Aducanumab four billion of US-could bring in dollars annually. This week has presented Biogen Details of the new results to a conference in San Diego, in order to convince the many sceptics in the ranks of science. What’s behind it?
Brain swelling as a side effect
The antibody Aducanumab can remove the Protein fragment Amyloid from the brains of Alzheimer’s patients. However, the success of the remedy depends, apparently, much of the dose that a Patient receives over the period of the treatment. It still seemed to be in March so, as the drug would not work, says Biogen because of the fact that the dosage was at the beginning of the study, in the case of too many patients, too low.
In fact, the new data suggest that high-dose Aducanumab can slow down the progression of the disease in Alzheimer’s disease in the Early and preliminary stage of something. A miracle cure but is not for sure.
In order to measure the success of the drug, the researchers conducted a Test that assesses the cognitive performance. Patients were treated with Aducanumab, cut them off at the end of the treatment period of 78 weeks, an average of 0.39 points better than those who had only received a Placebo. Although this is a statistically significant difference, doubt some of the experts that this difference will have no effect whatsoever on the lives of those Affected. Therefore, one to two points would be a minimum difference necessary.
It is also questionable how workable the therapy in the practice would be. In the treatment with the high doses of medication, a brain swelling developed more than every third Patient as a side effect. Although this resulted in only 20 to 30 percent of the Affected complaints. Nevertheless, experts fear that the brain of the patient should be regularly with a nuclear spin recordings monitored. This is expensive. Almost a quarter of the participants broke off also the therapy for various reasons.
Difficult decision for the admissions authority
Biogen and experts called by the company on the Podium, widely used at the presentation in San Diego nevertheless, Confidence in the approval process of the drug. “All these data suggest that the disease is affected. This means that the effects will grow over time,” said Paul Aisen, an Alzheimer’s expert from the University of Southern California.
Scientifically, this statement is not evidenced, the two investigations had not lasted long enough. It is also possible that the effects persist only temporarily. In order to clarify this, it would take further investigation, which would, however, take even a few more years. Many are calling this third study also, because Biogen can support his new findings only one of the two studies performed, in the second, no effects showed up in spite of the recalculations. The company also explains the too low dosages.
“Further studies are needed to assess the importance of Aducanumab for Alzheimer’s treatment,” says Michael Heneka, Director of the clinic for Neurodegenerative diseases and geriatric psychiatry at the University of Bonn. “A therapy, which can take the disease to their horror, will likely need to are made of several different drugs exist.”
Must judge at the end of the American reviewers of the Food and Drug Administration (FDA), which decide on the admission of the drug. “You will have a very difficult Job,” said Eric Siemers, a former Alzheimer’s disease researcher at Eli Lilly, who was not involved in the study. An Analyst estimated the probability that Aducanumab it creates, to less than 50 percent.