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 Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
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