Biogen and Eisai’s aducanumab (Aduhelm) was granted approval by the US Food and Drug Administration (FDA) after a long struggle with many doctors believing there is little evidence for effectiveness. The approval came through FDA’s accelerated approval pathway. The drugs approved through accelerated approval pathway use surrogate endpoints, enabling a faster FDA Approval in diseases with large unmet needs. For example, the last approved drug for Alzheimer’s was in 2003 for Memantine, a low to moderate affinity N-methyl-D-aspartate receptor (NMDAR) antagonist to slow the loss of neurological abilities in Patients with Alzheimer’s Disease.
Aducanumab is also the first and only therapy that targets the underlying disease process: the pathophysiology of the condition being amyloid-beta plaques. The drug was licensed by Biogen in 2007 from Neurimmune under a collaborative development and license agreement, and Eisai collaborated with Biogen in 2017 for further development and Global commercialization of Aducanumab.
Alzheimer’s Disease affects millions of Americans, primarily older people. The efficacy was evaluated in 3,482 patients under three separate studies involving double-blind, randomized, placebo-controlled trials with ranging doses and having a surrogate endpoint of reduction in amyloid-beta plaques. The quantification of this Amyloid-beta plaque was done using positron emission tomography (PET) imaging in brain regions believed to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.
The drug received a fair amount of skepticism as one of its studies in Phase III trial per the primary end point with reduced amyloid plaques while the other study did not meet the primary endpoint.
Adulhem prescription will include a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that will resolve over time and have some side effects in some patients, including headaches confusion, dizziness, vision changes, or nausea. The other warning for Adulhem also includes hypersensitivity reactions, including angioedema and urticaria.
Biogen and Eisai Inc. are working hard to negate the criticism on approval and usage of Aduhelm through the launch of multiple initiatives to help patients with Alzheimer’s in guiding them through the whole journey from diagnosis to treatment. Biogen provides Personal Biogen Support Service for one-on-one support to Alzheimer’s Patients and plans to enter a multi-year agreement with the Veterans Health Administration (VHA) to access veterans of whom 48 percent are 65 years and older. Biogen is also working with The National Association of Free and Charitable Clinics (NAFC) for affordable access to healthcare and plans a tie-up with CVS Health’s Project Health for cognitive screening. The yearly cost of Adulhelm is expected to cost USD 56,000 per patient, and Biogen is also working to collaborate with Cigna Corporation, a global health service company, to streamline the access path to the drug. These initiatives will ease accessibility and affordability to enhance its market presence and serve this underserved patient population.