The pharmaceutical industry is eagerly awaiting a decision by US regulators on potential blockbuster Alzheimer’s drugs. This drug is controversial, but if approved, it will become the first new treatment for this debilitating disease in years.
The US Food and Drug Administration is expected to announce on Monday whether to approve Biogen’s drug aducanumab, which claims to slow the progression of Alzheimer’s disease.
Why is this important?
If aducanumab is approved, this will be one of the most important decisions the FDA has made over the years.For many Alzheimer’s patients and their families, it is called revolutionary in a field where there are few treatments. No new medicine Approved since 2003.
However, the drug produced by Biogen and Japan’s Eisai has been involved in controversy, and many people believe that this treatment does not work at all.
In January of this year, the FDA delayed its decision after several months of delay. Pharmaceutical investors and the 6 million Alzheimer’s patients in the United States are waiting nervously for the conclusion of the regulator.
“There is no doubt that this is the biggest dual event in the biopharmaceutical sector in 2021,” UBS analyst Colin Bristow said of the approval or rejection of the drug.
How does the drug work?
Aducanumab is a monoclonal antibody therapy that can be injected intravenously into patients with moderate Alzheimer’s disease.
Biogen said that the drug binds to beta-amyloid molecules to form plaques and break down clumps in the brain, thereby reducing the progression of Alzheimer’s disease and allowing people to continue to perform daily tasks such as cleaning and shopping.
The drug test”Amyloid hypothesis“, its supporters believe that the accumulation of plaque in the brain causes Alzheimer’s disease.
Howard Felit, the founding executive director of the Alzheimer’s Disease Drug Discovery Foundation, called it “the first rigorous test of the amyloid hypothesis.”
What is the controversy surrounding drugs?
After a series of problems in Biogen’s clinical trials, many scientists dispute whether aducanumab is effective.
Biogen Stopped two trials After an independent committee said that the drug would not be effective. But in October 2020, the company stated that a new analysis of a larger trial data set showed that the drug was effective when administered at higher doses.
Biogen has also been criticized for providing analysis after the trial, and some scientists said its data were not enough to obtain regulatory approval. In November, the FDA advisory panel fight back According to the findings of the agency “Conclusive evidence” That aducanumab worked.
Caleb Alexander, a professor at the Bloomberg School of Public Health at Johns Hopkins University, said: “There is a clear and clear boundary. A product must be able to pass through to enter the market. The product does not.” Panel members.
“If they approve, I will fall off my chair,” he said, adding that the green light “will mark one of the most important and worst decisions the FDA has made in recent history.”
Why are so many people opposed to drug use?
A series of pharmaceutical companies tried to prove the amyloid hypothesis and developed a drug to slow the progression of Alzheimer’s disease, but all failed. There is little evidence that removing amyloid can reduce the progression of the disease.
Suspended trials include Pfizer and Johnson & Johnson abandoned research in 2012 and Merck’s failed trial in 2017. last year, Eli Lilly and Roche Neither drug has slowed down the rate of cognitive decline.
What happens if it is approved?
Approval will be welcomed by Alzheimer’s patients as a way of moving forward, and at the same time as a proof of Biogen, which has been fighting against criticism of its drug development and treatment for many years. .
The Alzheimer’s Association has urged the FDA to approve aducanumab, saying that any treatment that gives patients more time is worthwhile.
Analysts expect the drug to become Biogen’s best-selling product, although revenue estimates vary.
Matthew Harrison, head of biotechnology research at Morgan Stanley, said that patient needs may be great, but even with approval, some doctors refuse to use aducanumab. “Investors are not sure what this dynamic ultimately means.”
He expects Biogen’s sales to reach 7 billion U.S. dollars by 2030, while UBS’s Bristol expects global annual sales to reach a peak of 18 billion U.S. dollars.
“This will be one of the largest drugs in the industry,” Bristol said.
What happens if it is rejected?
Refusal of adukumab is a blow to Alzheimer’s patients, who are hoping to use the drug to slow down mental decline.
According to the Alzheimer’s Association, more than 6 million people in the United States suffer from this disease, and many diseases have Deteriorating during the coronavirus pandemic Because it reduces the contact between relatives to slow down the spread of the virus.
Rejection will also be a heavy blow to Biogen. Biogen has spent millions of dollars on drug research and development, but has fallen behind in other areas. After the previous announcement about the drug, the company’s stock price fluctuated sharply.
“Aducanumab has really hurt Biogen for a while because it is the company’s overwhelming focus and they are lagging behind in gene therapy. [and] New treatments for neurodegenerative diseases,” said Tom Shrader, managing director of BTIG.
What does the FDA’s decision mean for other companies?
The FDA’s green light may increase confidence in the amyloid hypothesis and promote investment in further research. Eli Lilly is trying donanemab, another drug that removes amyloid, and Biogen’s good news may boost confidence in Lilly’s research.
Bank of America analyst Geoff Meacham said that rejection “does not necessarily nail the coffin of the amyloid hypothesis” because Biogen’s controversial test is difficult to compare with other tests. At the same time, advances in imaging technology have made it possible to screen patients more effectively, first to understand whether there is amyloid in their brains.