On November 6, the Food and Drug Administration is convening a meeting of outside experts to review the data from two Phase 3 clinical trials of a new drug developed for treating cognitive and functional decline in early Alzheimer’s disease.
At the end of the meeting, this panel of experts is expected to vote on whether the drug should be approved, or not. The FDA isn’t required to follow the panel’s recommendation, but it will surely factor heavily into whatever decision the agency ultimately takes.
For decades, millions of Americans and their loved ones have waited for access to such a therapy as they have faced this relentless disease. Currently, more than 5 million Americans are living with Alzheimer’s disease. This number will only grow as our nation ages. By 2050, a projected 13.8 million Americans 65 and older may have Alzheimer’s.
The Alzheimer’s Association is committed to ending Alzheimer’s and all other dementia by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support.
At Altum, we share the same sense of purpose as those funding organizations, institutions, and researchers we serve and are excited to see the results of this promising breakthrough.
You can read the Alzheimer’s Association statement supporting approval to the FDA Advisory Committee, which will make its recommendation to the FDA.