Roche says Alzheimer’s remedy will get U.S. breakthrough designation By Reuters


© Reuters. FILE PHOTO: Signs are seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, the United States, Aug 29, 2020. REUTERS / Andrew Kelly


ZURICH (Reuters) – Roche announced on Friday that its gantenerumab antibody had been granted breakthrough therapy for the treatment of Alzheimer’s disease by the US Food and Drug Administration.

Like many other drug candidates for the treatment of this debilitating disease, gantenerumab was developed to neutralize beta-amyloid plaques, which are believed to be the drivers of brain cell death.

The Swiss pharmaceutical giant said the US breakdown designation is based on data showing that gantenerumab significantly reduced amyloid plaques in the brain in ongoing studies.

Levi Garraway, Roche’s chief medical officer and head of global product development, said the designation “strengthens our confidence in gantenerumab, which would be the first subcutaneous drug for the treatment of Alzheimer’s disease with the ability to be used at home.”

Analysts had said there could be an accelerated application for approval of gantenerumab in the US that could become a blockbuster if it works.

The quest for an Alzheimer’s cure that would inevitably gross drugmakers billions of dollars has been marked by more than 100 failures, though researchers are still hoping to tame a disease that affects nearly 6 million Americans and more than 40 million people worldwide affects and it grows more frequently.

Roche will complete a Phase III study with the drug in the second half of next year. In July, CEO Severin Schwan said there was an urgent need to find a way to meet these unmet medical needs and provide treatment to patients as soon as possible.

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