Gantenerumab from Roche Receives Breakthrough Therapy Designation for Alzheimer’s

Following the accelerated approval of Aduhelm (aducanumab) by Biogen, other companies are also seeking approval for their Alzheimer’s therapies. On October 8, 2021, Roche announced that its antibody named gantenerumab, a beta-amyloid plaque neutralizer, has been granted breakthrough therapy designation by the FDA. This designation was based on clinical trial data which showed reduction in brain amyloid plaques, a biomarker that Aduhelm also targeted and was the basis for its FDA approval. (1) 

In a statement, Levi Garraway, Roche’s chief medical officer stated that the company is looking to complete Phase III trial for gantenerumab later next year. If approved, the drug will be the first subcutaneous medication to treat Alzheimer’s with the potential option for at-home administration.(1)  

Aduhelm’s controversial approval has opened the door for competitors to seek FDA approval for disease-modifying treatments for Alzheimer’s. Aside from Roche, Eli Lilly also released a statement in July of its plan to seek FDA’s accelerated approval for donanemab, its most promising Alzheimer’s candidate, by the end of the year.(2)