The pharmaceutical industry is anxiously awaiting a US regulator’s decision on a potential Alzheimer’s disease drug. The drug is controversial, but if approved, it would be the first new treatment for this debilitating disease in years.
The U.S. Food and Drug Administration is expected to announce Monday whether it approves Biogen’s drug aducanumab, which it claims slows the progression of Alzheimer’s disease.
Why is this important?
If aducanumab is approved, it would be one of the most important decisions the Food and Drug Administration has made in years. For many Alzheimer’s patients and their families, it will be hailed as a revolutionary in an area where few treatments exist. No new drugs It has been approved since 2003.
But the drug, made by Biogen along with Japan’s Eisai, has been mired in controversy, with many arguing that the treatment simply doesn’t work.
In January, the Food and Drug Administration postponed its decision after months of delays. Pharmaceutical company investors, as well as the 6 million people with Alzheimer’s disease in the United States, anxiously await the regulator’s conclusion.
“Without a doubt, this is the biggest bilateral biopharma event of 2021,” said Colin Bristow, an analyst at UBS, referring to the drug’s approval or rejection.
How does the medicine work?
Aducanumab is a monoclonal antibody treatment given intravenously to patients with moderate Alzheimer’s disease.
Biogen says the drug binds to beta-amyloid molecules that create plaques in the brain and break down clumps, thus reducing the development of Alzheimer’s so people can continue to perform daily tasks such as cleaning and shopping.
real estate testingamyloid hypothesis‘, whose proponents believe that plaque buildup in the brain causes Alzheimer’s disease.
Howard Villette, founding executive director of the Alzheimer’s Drug Discovery Foundation, called it “the first rigorous test of the amyloid hypothesis.”
What are the controversies about drugs?
Several scientists argue that aducanumab works at all after a series of problems in the clinical trials of Biogen.
In March 2019, Biogen She stopped her experiment After an independent commission said the drug would not be effective. But in October 2020, the company said a new analysis of a larger experimental data set showed the drug worked when given at a higher dose.
Biogen has also been criticized for providing the analysis after its trials ended and some scientists say its data is insufficient to merit regulatory approval. In November, the Food and Drug Administration’s advisory committee hit back In the findings of the agency ‘Strong evidence’ that aducanumab works.
Caleb Alexander, a professor at the Johns Hopkins Bloomberg School of Public Health, and one of the team members said.
“I’d get out of my seat if they agreed to it,” he said, adding that the green light “would represent one of the most important and vulnerable decisions the FDA has made in recent history.”
Why do so many people oppose drugs?
A series of drug companies tried and failed to prove the amyloid hypothesis, and he created a drug that slows the progression of Alzheimer’s disease. There is little evidence that removing amyloid reduces disease progression.
Aborted trials include the canceled Pfizer and Johnson & Johnson study in 2012 and the failed Merck trial in 2017. Last year, Elie Lilly and Roche Two drugs also failed to slow the rate of cognitive decline.
What happens if it is approved?
The approval would be welcomed by those living with Alzheimer’s as a way forward, as well as an excuse for Biogen, which has faced criticism for its handling of drug development for years.
The Alzheimer’s Association urged the US Food and Drug Administration to approve aducanumab, saying that any treatment that gives patients more time is worth it.
Analysts expect the drug to become a popular seller for Biogen, although revenue estimates vary.
Matthew Harrison, head of biotechnology research at Morgan Stanley, said patient demand is likely to be large, but some doctors have refused to give aducanumab even if it has been approved. “Investors are not sure they understand what this dynamic will ultimately mean.”
Biogen is expected to generate $7 billion in sales by 2030, while UBS’s Bristow forecasts annual sales of $18 billion worldwide.
“It’s going to be one of the biggest drugs in the industry,” Bristow said.
What happens if it is rejected?
Rejecting aducanumab would come as a shock to people with Alzheimer’s who pin their hopes of a slower mental decline on the drug.
More than 6 million people in the United States live with the disease, according to the Alzheimer’s Association, and many more conditions Worsened during the coronavirus pandemic Contact between loved ones has been reduced in order to slow the spread of the virus.
Rejection would also be a severe blow to Biogen, which has spent millions developing the drug and has fallen behind in other areas. The company’s shares fluctuated significantly after the previous announcements of the property.
“Aducanumab has really hurt Biogen for a while because it was such a big focus for the company, they were late with the gene therapy [and] “New neurodegenerative therapies,” said Tom Schrader, managing director of BTIG.
What will the FDA’s decision mean for other companies?
The green light from the US Food and Drug Administration (FDA) is likely to instill confidence in the amyloid hypothesis and boost investment in further studies. Eli Lilly is trialing Donanemab, another drug that removes amyloid, and the positive news for Biogen is likely to bolster sentiment toward Lilly’s study.
Jeff Meacham, an analyst at Bank of America, said the rejection “would not necessarily put a fatal nail in the coffin of the amyloid hypothesis” because Biogen’s controversial experiments are difficult to compare to others. Meanwhile, imaging technologies have advanced so that patients can be more effectively screened to see if they have amyloid in their brains in the first place.