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U.S. regulators have approved the first new treatment for Alzheimer’s disease in nearly two decades, giving the green light to the drug developed by Biogen despite a scientific debate over whether the drug works.
At an important time for 35 million people worldwide who suffer from cognitive impairment, the U.S. Food and Drug Administration on Monday approved that adducumum, a venous infusion, will cost $ 56,000 a year in a course.
Aducanumab, which will be sold under the brand name Aduhelm, is the first Alzheimer’s drug to slow the progression of the disease. The drug breaks down the amyloid plaques that form in the brain, which some scientists believe cause the disease.
All of the other drugs approved for Alzheimer’s so far treat symptoms instead of slowing or reversing the course of the disease.
Shares of a Massachusetts biotechnology company in Biogen rose 53 percent to a record $ 428 after trading resumed Monday afternoon. The day ended 38 percent higher at $ 395.85. The share price of Japanese physician Eucai, a partner in the development of adducanumab, rose 56 percent.
The drug has been surrounded by controversy for years, with many scientists opposing its acceptance because of the scant evidence that it works.
“We are well aware of the focus on this approval,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. However, the agency concluded that adducanumab is “reasonably likely” to help patients and that the overall benefits of the medication outweigh the risk to patients.
The agency approved the drug last year after it was approved by its own committee of scientific advisers, arguing that the clinical trials of the drug did not provide evidence that it works.
Cavazzoni acknowledged these disagreements, but said the medication removed amyloid plaques and that the agency “hoped” it would reduce the rate of cognitive decline in people with the disease.
The drug was approved using the so-called accelerated route, which allows the FDA to approve the drug for a serious illness with few treatment options, even before conclusive evidence that it is effective.
Biogen will have to make a major assertion test now to see if the drug has a clinical advantage, a process that will probably take years. In the meantime, the marketing and sale of adducumumab will be permitted.
Although the drug has been tested on patients with mild forms of Alzheimer’s, anyone with the disease will be able to access the medication, according to its label, so Biogen’s huge revenue increases dramatically.
The $ 56,000 price for a one-year course is also much higher than analysts expected, and it also has the highest estimates of $ 24,000. The Institute for Clinical and Economic Review, a U.S. nonprofit that tries to calculate the price of drugs, said the company should charge less than $ 2,500.
“This is a game changer for Biogen,” said UBS analyst Colin Bristow, who added that the breadth of the eligible population was a “definitive surprise”.
Michel Vounatsos, CEO of Biogen, said: “This historic moment is the result of more than a decade of research into the complex area of Alzheimer’s disease.”
In theory, the FDA could revoke the permit if the assertion trial fails or does not end, even if the agency makes few cases of the drug out of the market after it has been made available to patients.
Clinical trials of the drug have been embroiled in controversy. In March 2019, Biogen he stopped two investigations an independent commission said the drug would not be effective. That year, in October, the company said a new analysis of a larger set of test data showed when the drug worked. it is given in a higher dose.
The Alzheimer’s Association has welcomed the decision, saying it is a new day of hope for Alzheimer’s patients. “This recognition is a victory for people living with Alzheimer’s and their families,” said Harry Johns, charity president, who added that the new trial “fully supports” it.
John Hardy, a professor of neuroscience at the University of London, said: “I am delighted to have been approved by adducanumab.
The FDA’s decision is enough to investigate Alzheimer’s beyond Biogen, despite the costly failures it has spent searching for the “amyloid hypothesis” that has cost billions of dollars. Shares of Eli Lilly, who is currently testing his drug for amyloid cleansing, jumped 10 percent.
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