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The approval of Biogen’s Alzheimer’s medicine has aroused the interest of money marketers in the face of the controversy over the causes of the disease, despite their failure in the field and the radical dismissal of the theory by many scientists and doctors.
Biogen’s $ 56,000 per year product was the first Alzheimer’s treatment for nearly two decades to receive green light by U.S. officials last month. Called aducanumab, it is a first-line treatment to reduce cognitive impairment, rather than helping patients cope with symptoms.
The product was made in a circular motion mind amyloid, who advocate this, believe that high levels of protein produced in the brain lead to Alzheimer’s. Biogen claims that the drug removes fluid from the brain and reverses the disease.
The concept of amyloid divides, with some scientists arguing that there is little evidence that removal of the amyloid slows the progression of Alzheimer’s.
Alberto Espay, a professor of neuroscience at the University of Cincinnati, said that “any research we have done” has challenged the assumptions of amino acids but still “there is still no evidence to the contrary.”
Several pharmaceutical companies including Merck and Johnson & Johnson have tried but failed to ensure that the purification of amyloid plaques is directly linked to improved detection. But the pharmaceutical companies have persevered, attracted by the huge market growth and the patients who are facing a few effective treatments. About 35m people worldwide have Alzheimer’s disease, about 6m of them in the US.
In recognition of aducanumab, the Food and Drug Administration stated that it isobviously”For the treatment to reflect the benefits to the patients.
Despite this, the FDA’s idea has attracted interest in this area of Alzheimer’s research and offers hope to other medical companies that have spent billions to follow a similar approach.
“The FDA’s approval will encourage other funds to become an idea that would have been a long-held scam,” added Espay.
Last week, regulators submitted two new drug-testing trials, meaning their review and approval of the agency’s acceleration.
U.S. pharmaceutical company Eli Lilly has said it will apply for approval of its drug, donanemab, by the end of this year, an announcement that sent its shares 9%.
A Japanese drug manufacturer, Eisai, who has combined aducanumab Biogen with the latest Alzheimer’s drug, lecanemab, is actively pursuing this study again, without criticism.
“We have always believed that the amyloid process is the cause of Alzheimer’s disease,” Ivan Cheung, chairman of Eisai, told the Financial Times.
“I think. . . The FDA’s recommendation would also help to sell drugs not only amyloid drugs but also Alzheimer’s alternatives, “he said, adding:” We strongly believe that amyloid removal will play a positive role in the spread of the disease to these patients if treated early. ”
While it is still too early to see if money will be poured into the new drug, both sides of the controversy believe the FDA’s idea is to increase revenue in the region and urge drug manufacturers not to ignore past failures in trying to seize the market, which is said to be worth billions in the US alone.
A Swiss drug user in Roche is currently trying to cure the disease. Researchers in Bernstein expect Eli Lilly, Biogen and Roche to achieve a 50, 30 and 20% share in the Alzheimer’s augmented long-term market, if all the company’s drugs are approved by the FDA.
“History has certainly shown that FDA practices such as aducanumab approval often lead to significant interest rates,” said Rebecca Edelmayer, executive director of the Alzheimer’s Association.
Some are concerned that a closer look at amyloid detoxification will prevent us from focusing on research into other Alzheimer’s drugs that may be more effective.
“Taking research results and bringing them to patients involves having money. How are we going to make money when all the big money becomes amyloid-related stuff? ”Asked George Perry, professor of neurology at the University of Texas San Antonio.
He also said that the promotion of amyloid detoxification would not lead to a more comprehensive study of Alzheimer’s disease. and that “the best thing to do is to give all these companies a license and then to look for other things.”
Researchers expect Biogen to earn $ 10bn from the annual sales price from aducanumab and the company’s shares remain for two years even though two House committees will seek approval for the price of the drug.
“The acceptance of aducanumab should not be seen by investors as a confirmation of the concept of amyloid,” says Espay. “This is a good thing for companies that were smart but not scientific in nature.”
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