June 7, 2021 update: In a long-awaited decision, the Food and Drug Administration on Monday, June 7, approved Aducanumab as the first new medication for Alzheimer’s disease in nearly two decades and the first to treat the underlying pathology of the disease – not just its symptoms.
The drug, which will go by the brand name, Aduhelm, was approved by the F.D.A. under the agency’s accelerated approval pathway, which can be used for a drug that is meant for a serious life-threatening illness such as Alzheimer’s disease and provides a meaningful therapeutic advantage as compared to existing treatments for that same condition.
Under the accelerated approval provisions, which provide those with Alzheimer’s with earlier access to the treatment, the F.D.A. is requiring a new randomized, controlled clinical trial called a Phase 4 trial, to verify the drug’s clinical benefit. The results of this post-market study are intended to erase any uncertainties about the drug’s ultimate clinical benefit or can lead to the F.D.A.’s initiation of proceedings to withdraw approval of the drug.
February 1, 2021 update: The FDA has announced that it will extend the review period for aducanumab, an investigational therapy for Alzheimer’s disease developed by Biogen and Eisai. The three-month extension puts the new deadline for a decision by the FDA at June 7, 2021.
Aducanumab is a synthetic, or man-made, antibody designed to remove the misshapen beta-amyloid proteins, whose toxic clumps lead to the death of nerve cells (neurons) seen in the brains of those with Alzheimer’s. The FDA has asked for additional analyses and clinical data which is considered a Major Amendment to the application and requires additional time for review. This news suggests that the FDA is giving aducanumab closer consideration. Alzheimer’s New Jersey continues to support and appreciate the priority given aducanumab by the FDA and along with many in the medical and scientific community, continues to be optimistic that aducanumab will pass the rigorous FDA scientific review and emerge as a viable therapy for those impacted by Alzheimer’s disease.
If approved by the FDA, aducanumab would be the first new Alzheimer’s drug therapy in almost two decades. While not a cure, it would be the first drug therapy designed to treat the underlying pathology of the disease – slowing cognitive decline – not just symptoms.
November 9th, 2020 update: This past Friday, November 6, the Food and Drug Administration (FDA) Peripheral Central Nervous System Drugs Advisory Committee met to review data for a new potential pharmaceutical treatment for Alzheimer’s disease, known as aducanumab. In a disappointing decision, the committee overwhelmingly ruled that the evidence, presented by pharmaceutical companies Eisai and Biogen, failed to support aducanumab as an effective treatment to slow cognitive decline in people with Alzheimer’s disease. The decision by the committee was based on an evaluation of the results from the two identical, large scale international clinical trials that were conducted by Eisai and Biogen, referred to as studies 301 and 302, that showed conflicting evidence – one negative and one positive. The committee seemed to suggest that a third Phase 3 trial should be conducted which, unfortunately, could take up to 4-years.
Recognizing the significant impact for individuals with Alzheimer’s disease, the FDA granted priority review for aducanumab and is expected to make a final decision no later than March 7, 2021. The FDA does not have to follow the recommendation of the advisory committee.
“We continue to be hopeful based on the support of the medical and scientific community support for approval, including support from the Alzheimer’s Association in Chicago and UsAgainstAlzheimer’s in Washington, DC,” said Ken Zaentz, Alzheimer’s New Jersey President and CEO.
On November 6, the Food and Drug Administration (FDA) Advisory Committee is meeting to review data for a new pharmaceutical treatment for Alzheimer’s disease, known as aducanumab. The Advisory Committee review will be significant in determining FDA approval.
Pharmaceutical companies Eisai and Biogen officially sought FDA review of aducanumab this year. Recognizing the impact, the FDA granted priority review and established an action date of March 7, 2021 for final approval.
If approved by the FDA, aducanumab would be the first new Alzheimer’s drug therapy in almost two decades and the first designed to treat the underlying pathology of the disease – slowing cognitive decline – not just symptoms.
“This represents a critical time in the fight against Alzheimer’s disease, and Alzheimer’s New Jersey enthusiastically supports the priority that the FDA has provided for this review and shares in the hope of this new drug treatment option,” said Kenneth Zaentz, President and CEO of Alzheimer’s New Jersey.
The approval of aducanumab could have a significant impact for individuals with Alzheimer’s disease. In New Jersey alone this could make a critical difference for more than 600,000 individuals and families struggling to cope with the devastation of Alzheimer’s disease.
“We were encouraged by the continued medical and scientific community momentum, including the submission of a letter of support for the drug’s approval to the FDA Advisory Committee by the Alzheimer’s Association in Chicago,” said Zaentz.
Alzheimer’s New Jersey is a statewide non-profit organization dedicated to providing care and assistance for New Jersey individuals and families and support of medical and scientific research related to Alzheimer’s disease and related dementias.
For additional information please contact the Alzheimer’s New Jersey Helpline at 888- 280-6055 or visit www.alznj.org
