FDA grants approval for ADUHELM as the first and only Alzheimer’s disease treatment

USA – U.S. Food and Drug Administration has approved Biogens’ Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans, the first new treatment approved for Alzheimer’s since 2003.

Aduhelm has been 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.

Currently available therapies only treat symptoms of the disease whereas this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research remarked

Patients receiving the treatment during clinical studies had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque.

The most common side effects of Aduhelm have been indicated to be amyloid-related imaging abnormalities (ARIA), headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation. 

Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

Aduhelm has been granted Fast Track designation, which seeks to expedite the development and review of drugs that are intended to treat serious conditions where initial evidence showed the potential to address an unmet medical need.

Following the approval, Biogen and Eisai Inc. have announced a range of programs intended to support access to ADUHELMTM for all qualified patients, including traditionally underserved populations.

These initiatives aim to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment.

“We feel a great sense of purpose and responsibility to turn the hope of today’s FDA approval of ADUHELM into a reality for people living with Alzheimer’s disease and their families,” said Alisha Alaimo, President of Biogen U.S.

Ivan Cheung, Chairman of Eisai Inc. and President, Neurology Business Group, Eisai Co., Ltd, coined that ADUHELM is the first new treatment for Alzheimer’s disease to be approved in the U.S. in nearly 20 years, bringing long-awaited hope for patients and families living with this neurodegenerative disease. He also emphasized on the need for Eisai and Biogen to not only establish these access programs but to champion their reach, especially in underserved patient communities

Biogen has availed Support Service Coordinators to provide one-on one support to patients and their families by answering questions about Alzheimer’s and ADUHELM treatment, assessing financial option for eligible patients, locating healthcare providers and infusion sites as well as any other topics.

In partnership with LabCorp and Mayo Clinic Laboratories, Biogen has also established a program to help physicians and patients access cerebrospinal fluid (CSF) diagnostic laboratory testing to aid in the diagnosis of Alzheimer’s disease.

Collaborations

Biogen and Eisai are committed to addressing health equity for underserved and underrepresented populations that are at higher risk for Alzheimer’s disease. As a result, they have partnered with different agencies and organizations in an effort to accomplish this mission.

With the Veterans Health Administration (VHA), Biogen is working to finalize a multi-year agreement in order to support access for veterans throughout the VHA system. The VHA is the largest integrated health system in the U.S., with nine million enrolled veterans, approximately 48 percent of which are over the age of 65.

Biogen has also entered into an initiative with CVS Health, focused on the importance of brain health, screening and disease education. As part of this effort, cognitive screenings will be available through CVS Health’s Project Health, a longstanding health services program helping address care disparities for uninsured and underinsured Americans, particularly in racially and ethnically diverse communities.

In addition, Biogen is working with The National Association of Free and Charitable Clinics (NAFC), a nationwide network of 1,400 clinics that focuses on ensuring the medically underserved have access to affordable quality healthcare. Together, the organizations intend to develop a program that supports brain health and culturally competent Alzheimer’s disease education for patients and healthcare providers within the NAFC member clinic network.

We all recognize that the optimal delivery of healthcare requires multiple stakeholders working together,” said Sree Chaguturu, M.D., Chief Medical Officer, CVS Caremark. 

Cost

Currently, Alzheimer’s disease represents a significant economic burden for patients, caregivers and society, with more than 11 million Americans providing an estimated 15.3 billion hours of unpaid care in 2020. The annual cost of care for Alzheimer’s disease and other dementias in the U.S. is over $600 billion and lifetime care for someone with Alzheimer’s disease is estimated to cost approximately $500,000 per patient, which is primarily borne by patients’ families as an out-of-pocket expense.

Biogen has established the price of ADUHELM based on the overall value this treatment is expected to bring to patients, caregivers, and society, while reflecting key principles such as innovation, access and sustainability. Biogen and Eisai are committed to providing access to ADUHELM for patients across a spectrum of financial situations.

Cigna Corporation, a global health service company, and Biogen intend to enter into a value-based contract to ensure that there is a streamlined path to access treatment for patients consistent with the population in which ADUHELM was studied.

Alzheimer’s disease imposes a tremendous burden on patients, caregivers and society as a whole,” said Dr. Steve Miller, Executive Vice President and Chief Clinical Officer at Cigna. “Given the known infrastructure challenges in the U.S., we are working to ensure that the patients who will benefit most from this new treatment have a clear path to access it.”

Biogen and Eisai have committed to not increasing the price of ADUHELM for the next four years.

Alzheimer’s disease is a progressive neurological condition that impairs thinking, memory and independence, leading to premature death. It is characterized by changes in the brain, including the abnormal accumulation of toxic amyloid beta plaques, which begins approximately 20 years before patients exhibit symptoms of the disease. Mild cognitive impairment due to Alzheimer’s disease is one of the earliest symptomatic stages of the disease when symptoms start to be more visible and can be detected and diagnosed.

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