Global biotech giant Roche has announced that the U.S. Food and Drug Administration (FDA) has awarded its candidate Alzheimer’s Disease drug gantenerumab Breakthrough Therapy Designation, bringing it closer to finally getting a full FDA approval.
The decision is based on promising results from the ongoing Marguerite RoAD and SCarlet RoAD open-label extension trials, showing a significant reduction in brain amyloid plaque in Alzheimer’s patients. Findings from both trials have been incorporated into the ongoing global Phase III trials GRADUATE I and II. The pivotal GRADUATE trials are assessing the effect of gantenerumab in over 2,000 participants over the last two years.
Gantenerumab is an IgG1 antibody that can remove brain amyloid plaques by binding to aggregated beta-amyloid structures. The GRADUATE trials are looking into the safety and efficacy of the drug in patients diagnosed with prodromal-to-mild Alzheimer’s Disease. The massive study covers 250 centers in over 30 countries, where patients are given a 1,020 mg dose of gantenerumab monthly with optimized titration. Both GRADUATE 1 and 2 are expected to be done by mid-2022.
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