The U.S. Food and Drug Administration (FDA) has recently announced approval for Leqembi, a drug developed by BioArctic proven to reduce the rate of Alzheimer's disease progression. Additionally, the Centers for Medicare and Medicaid Services (CMS) announced Medicare will provide broad coverage of Leqembi.
"The full, traditional approval of Leqembi in the U.S., combined with the broad Medicare reimbursement, is a paradigm-shifting step in the fight against Alzheimer's disease," said BioArctic CEO Gunilla Osswald. "Doctors in the U.S. will now have a tool to combat this terrible chronic disease already at an early stage, with the potential to provide clinically meaningful benefit for patients and their families."
Osswald acknowledged the work of partner Eisai, and expressed optimism on the treatment's future.
"More than two decades of research and development has led up to this moment, and I am impressed by the diligent efforts of our partner Eisai to ensure that this important innovation can now reach the patients BioArctic was founded to serve," Osswald said. "I am full of gratitude and hope for the future."
Leqembi is the first and only FDA-approved treatment that has demonstrated the ability to reduce the rate of Alzheimer's disease progression.
According to BioArctic, Leqembi is an injection for intravenous use. The FDA's approval follows data from a Phase 3 global clinical trial. Results of the trial showed Leqembi treatment reduced clinical decline of cognitive and functional abilities by 27% when compared to a placebo and used in treatments of early Alzheimer's. Additionally, the trial measured a patient's ability to function independently by surveying caregivers of those diagnosed with Alzheimer's. The results noted 37% of patients benefited from Leqembi treatments in day-to-day activities such as being able to dress, feed themselves, and participate in community activities.
The CMS' plan to provide broad coverage of Leqembi is an important step for people living with Alzheimer's and their families, the Alzheimer's Association said in a statement. The decision to open up Medicare coverage to patients seeking treatment for Alzheimer's follows the extensive efforts by the Alzheimer's Association, bipartisan members of Congress, state attorneys, clinicians, and advocates from across the nation.
"Alzheimer's Association advocates have tirelessly shared their stories in congressional hearings and in rallies at the White House and in all 50 states about the impact that clinically meaningful treatment like Leqembi will have on their lives," said Robert Egge, the chief public policy officer at the Alzheimer's Association. "Today is an important advance in making access to this and future treatments a reality."
