First-of-its-kind Alzheimer’s drug gains US FDA approval

Biogen and Eisai's Aduhelm approved using the accelerated approval pathway after clinical trials demonstrated it reduced amyloid beta plaques by up to 71%
Biogen and Eisai’s drug, Aduhelm (aducanumab) has become the first new treatment to gain US Food and Drug Administration approval for Alzheimer’s since 2003 and the first therapy that targets the fundamental pathophysiology of the disease.
The drug was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
The accelerated approval was granted based on data from clinical trials demonstrating Aduhelm reduced by 59-71% amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, such as a reduction in clinical decline.
In a statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research said currently available therapies only treat Alzheimer’s symptoms.
“This treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” she said.
We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come,” said Michel Vounatsos, Chief Executive Officer at Biogen.
However, some analysts have questioned the high price tag of Aduhelm at $56,000 a year. In a note Tuesday, Stifel analyst Paul Matteis wrote that the general consensus was that Aduhelm would cost no more than $25,000 a year.
Speaking on CNBC Monday, Vounatsos defended the price tag as “fair”.
“Today the cost of Alzheimer’s is $600 billion to the US in terms of direct and indirect cost,” he said. “It is really time now that we invest some resources to treatment.”
Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks.
While the specific causes of Alzheimer’s disease are not fully known, it is characterized by changes in the brain—including amyloid plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections, affecting the ability to remember and think.
Related News
-
News mRNA therapy for ovarian cancer and muscle wasting
Researchers demonstrate results of a promising mRNA therapy for ovarian cancer and muscle wasting caused by cachexia, a condition associated with various types of cancers and chronic diseases. -
News Pfizer CentreOne Content Refinement Q3 media buy
For 40 years Pfizer CentreOne has been guiding drug projects to success. Here’s how our services make us an altogether different kind of CDMO: -
News Bora Pharmaceuticals expands development and manufacturing capacity with landmark acquisition
Taiwan-based CDMO Bora Pharmaceuticals have acquired niche generic drugs developer TWi Pharmaceuticals, expanding their outsourced development and manufacturing services with two additional manufacturing facilities. -
News Lonza and Touchlight collaboration to bring expanded end-to-end mRNA offerings
Through a collaboration with biotech company Touchlight, Lonza is set to expand their end-to-end offering for mRNA manufacturing with additional DNA raw material sources, including Touchlight’s doggybone DNA. -
News Oxford University presents promising phase II data for malaria vaccine
The malaria vaccine R21/Matrix-M, developed by researchers at Oxford University, has produced encouraging new data for the global effort against the mosquito-borne disease. -
News NextPharma to acquire Norway manufacturing site from Takeda
Biopharmaceutical company Takeda and CDMO NextPharma have announced an acquisition agreement in which Takeda will divest from their Asker, Norway manufacturing site, set to be acquired by NextPharma. -
News Gut instinct: molecular link between COVID-19 and serotonin cells in the gut
New research may provide further evidence of the gut’s role in SARS-CoV-2 infection and disease severity with a molecular link between serotonin-producing cells in the gut and COVID-19 disease severity. -
News Novavax COVID-19 vaccine receives backing from European Medicines Agency
The European Medicines Agency has backed the Nuvaxovid COVID-19 vaccine for adults as a booster shot to other COVID-19 vaccines.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance