There is no cure for Alzheimer's disease.
Drug companies have been trying to come up with viable treatments for a long time.
A recent study of a new Alzheimer's treatment may help companies and doctors decide if it's worth investing in. The full phase 3 study data of lecanemab was released by the two companies. The drug slowed the rate of decline in cognitive function in Alzheimer's patients. According to analysts, this positive result could lead to it being a blockbuster drug.
The results come from two companies, one focused on neurological diseases and the other on cancer and brain diseases. The Alzheimer's drug Aduhelm was approved by regulators in 2021, but flopped commercially after mixed results in clinical trials.
The validity of a hypothesis that's been a source of controversy in Alzheimer's research for years is now possible thanks to lecanemab.
The amyloid hypothesis is at the center of the science behind the drug. The clumps are thought to eventually kill brain cells and cause the disease to progress.
A number of companies focused on Alzheimer's treatment have used this theory to develop drugs that block the effects of the Alzheimer's genes. Despite the growing skepticism around the amyloid hypothesis and a series of failed drugs from companies like Eli Lilly and Pfizer, the results from Biogen and Eisai's Phase 3 study set the stage for the future.
If the data are poor, the study will either confirm the hypothesis or make it more questionable.
The drug lecanemab was used in the study to see if it could slow the cognitive decline associated with Alzheimer's. Those in the early stages of the disease will be treated with the drug.
A blockbuster success for the company, such as FDA approval of lecanemab, will be important to drive revenue growth as the company faces a modest decline in revenue over the next few years. Insider reached out to Biogen to inquire about lecanemab.
According to a recent analyst note, lecanemab could take over 10% of the Alzheimer's disease market three years after its launch, which would translate into more than $3 billion in annual revenue.
Some people thought the probability of a successful study was low. According to a survey done by physicians at the annual health conference, lecanemab has a 34% chance of succeeding.
lecanemb had a 43% chance of being a successful Alzheimer's treatment according to analysts.
If the drug failed to reduce the severity and progression of Alzheimer's in 18 months, it wouldn't mean the end of the companies working on similar treatments.
Results from treatments being pursued by other big drug companies are expected later this year and early next year.
He said that people's confidence in the amyloid hypothesis would go down further, but they would wait to see what the other data events show.
It's possible that negative results gave a boost to companies that are trying to find a cure for Alzheimer's. As the amyloid hypothesis has gained more scrutiny, a number of companies have begun to look at different ways to find better treatments for the disease. Though Biogen's drug is furthest along in development, it's not the only one being tested for Alzheimer's. There are 142 drugs that target the disease in 172 clinical trials.
It could be a huge success for Biogen because of the positive result.
More than 100 million people on Medicare and Medicaid are overseen by the Centers for Medicare and Medicaid Services. Both Aduhelm and lecanemb have been approved by the Food and Drug Administration, but Aduhelm was subject to intense scrutiny from the Centers for Medicare and Medicaid Services. Because Aduhelm is only covered for patients in clinical trials, those who want to use it in real life will have to pay the full price.
It is possible that the drug may be approved by the FDA but not receive adequate reimbursement from Medicare.
The trial with Biogen on lecanemab is designed to give both patients and the larger medical community a definitive answer about whether the drug really works.
He said that there shouldn't be a lot of interpretation about whether the drug should be approved for wide use.
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