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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.
"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.