The first subcutaneous injection: Roche's Alzheimer's disease drug received FDA breakthrough therapy designation

On October 8, Roche announced that Gantenerumab, an anti-amyloid beta antibody administered subcutaneously, has been approved by the U.

From: Roche official website

This qualification is based on the SCarlet RoAD and Marguerite RoAD trials and other studies where Gantenerumab significantly reduced amyloid plaque deposits in the brain

Roche stated that Gantenerumab has the potential for home delivery as the first subcutaneous AD therapy currently under development to enter the late clinical stage

AD is a progressive and fatal brain disease characterized by decreased memory, language, and other thinking abilities, as well as changes in mood and behavior

In June of this year, the FDA took the lead in accelerating the approval of Bojian’s Aducanumab based on biomarkers

In September, Eisai/Bojian submitted the BLA of its new Alzheimer's disease drug Lecanemab (BAN2401) to the FDA on a rolling basis, firing the first shot in the AD competition after Aducanumab