A new drug for Alzheimer’s disease in nearly 20 years was approved by health officials on Monday. The decision ignored warnings from independent consultants that the highly controversial treatment has not been shown to slow brain-damaging diseases.
The Food and Drug Administration says it has approved a drug developed by Biogen for patients with Alzheimer’s disease. The drug called Aduhelm is scientifically known as aducanumab (pronounced “add-yoo-CAN-yoo-mab”).
It is the only drug that US regulators have. said that there is a tendency to treat underlying diseases Instead of managing symptoms such as anxiety and insomnia, Biogen shares jumped after the FDA announcement, up 38 percent to close at $395.85.
such a decision This could affect millions of older Americans and their families. That will certainly spark controversy among doctors. medical researcher and patient groups There are also broad implications for standards used to evaluate experimental treatments. This includes only standards that show increased benefits. The FDA said it believes the drug̵7;s benefits for people with Alzheimer’s disease outweigh the risks.
“We are well aware of the interest in this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Ultimately, we decided to take the accelerated approval route. It is a path that is intended to provide earlier access to potentially valuable treatments for patients with critical illnesses with unmet needs.”
Biogen’s new drug co-developed with Japanese company Eisai isn’t mind-blowing. only slowing it down in one study. This medication is injected every four weeks.
The FDA is requiring drugmakers to conduct follow-up studies to confirm the drug’s benefits for patients. If the study fails to show efficacy The FDA can pull the drug from the market. Although the agency rarely does that.
$30,000 to $50,000 per year
Biogen did not immediately disclose a price. Although analysts estimate that the drug could cost between $30,000 and $50,000 for one year of treatment.
A preliminary analysis by one group found that the drug would have to cost $2,500 to $8,300 a year to be of good value, based on “Small overall health benefit” suggested by company study The non-profit Institute for Clinical and Economic Review added that “any price is too high” if the drug’s benefit is not confirmed in a follow-up study.
Nearly 6 million people in the United States and many parts of the world have Alzheimer’s disease, which gradually attacks areas of the brain that are essential for memory, reasoning, communication and basic daily tasks. in the final stages of the disease Those who suffer will lose their ability to swallow. global burden of disease which is the most common cause of dementia This is expected to increase as millions of baby boomers become more advanced in the 60s and 70s.
The need for treatment for this disease is “urgent,” Dr. Cavazzoni said. Although Aduhelm’s data is complex in terms of clinical benefit, the FDA considers that there is substantial evidence that Aduhelm reduces the development of amyloid beta plaque. in the brain, and the reduction of these plaques tends to predict a significant benefit to patients.
Aducanumab aims to help remove a harmful group of proteins called beta-amyloid from the brain. Other experimental drugs have done this before. But it didn’t make a difference in patients’ ability to think, take care of themselves, or live independently.
A new therapy?
The pharmaceutical industry’s drug pipeline has been littered for years. where Alzheimer’s treatment has failed. It costs billions of dollars in research. The FDA green light is likely to revive investment in similar treatments that the drugmaker had previously withheld.
The new drug is made from living cells, which must be given by infusion at a doctor’s office or hospital. The most common side effect is inflammation in the brain. Most of them cause no permanent symptoms or problems.
The FDA drug review has become a flashpoint in a lengthy debate about standards used to evaluate treatments for difficult-to-treat conditions. And their family said the new treatment Even the slightest benefit guarantees approval. But many experts warn that giving green pills a dangerous precedent. By opening the door to safeguarding dubious interests.
The approval came despite a nasty assessment in November by the FDA’s panel of exogenous neurology experts. The group voted “no” for a series of questions about whether an analysis of data from a single study submitted by Biogen found the drug to be effective. not
Cambridge City Massachusetts-Biogen Two 2019 drug studies were suspended after disappointing results suggest that aducanumab does not meet its goals of slowing mental and functional decline in Alzheimer’s patients. months later The company has reversed It announced that a new analysis of one study found the drug to be effective at higher doses. And the FDA has suggested that it should be reviewed. The company’s scientists say the drug’s initial failure was caused by some patients not getting the drug high enough to slow the disease.
But changing the dosage and the company’s after-fact analysis made the results difficult to interpret. This caused the suspicion of many experts. including those on the FDA’s board.