Genentech’s Alzheimer’s Drug Garners Breakthrough Therapy Designation
Genentech is conducting phase 3 trials of gantenerumab, an anti-amyloid antibody.
The FDA approved breakthrough therapy designation for Genentech/Roche’s treatment for Alzheimer’s disease (AD).
Gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, snagged the designation due to new data showing that the medication significantly reduced brain amyloid plaque, a pathological hallmark of AD, Genentech said in a press release.
The pharma maker’s two ongoing global, placebo-controlled phase 3 trials, GRADUATE 1 and 2, are evaluating gantenerumab in more than 2,000 participants for more than 2 years. They are expected to be completed in the second half of 2022.
Levi Garraway, M.D., Ph.D.
"This breakthrough therapy designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimer’s disease with the potential for at-home administration.” Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech, said in a statement.
Alzheimer's is the most common form of dementia, which affects more than 55 million people worldwide, and is projected to reach 78 million by 2030, Genentech said. “An enormous and growing public health challenge, it is predicted to cost the global economy a cumulative $20 trillion over the next decade, or the United States $2.8 trillion per year by 2030,” the pharma maker added.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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