Roche: groundbreaking Alzheimer's therapy in the USA

Roche announced on Friday that the antibody gantenerumab had been granted breakthrough therapy status for the treatment of Alzheimer's disease by the US Food and Drug Administration.

Like many other drugs used to treat this debilitating disease, gantenerumab aims to neutralize the beta-amyloid plaques that are believed to be the cause of brain cell death.

The Swiss pharmaceutical giant announced that its designation as a breakthrough drug in the US is based on data showing that ongoing studies have shown that gantenerumab has significantly reduced amyloid plaques in the brain.

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 that can be given at home."

Analysts had said that gantenerumab's approval application in the US could be accelerated as it could be a blockbuster if it proves effective.

The quest for a cure for Alzheimer's 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 are affected worldwide and which is occurring more and more frequently.

Roche will complete a Phase III study with the drug in the second half of next year. In July, CEO Severin Schwan stated that there was an urgent need to find a way to treat this unmet medical need and to offer patients therapy as soon as possible.