Impact of Breakthrough Therapy Designed for Alzheimers Disease Treatment


Biogen’s Aduhelm (aducanumab) became the first DMT to reach the AD market in early June 2021. The BTD for gantenerumab follows the FDA granting BTDs for Eisai and Biogen’s lecanemab (BAN2401) and Eli Lilly’s donanemab in late June 2021.

Aduhelm, lecanemab, and donanemab are intravenously administered mAbs, whereas gantenerumab would become the first subcutaneously administered mAb for AD.

This alternative route of administration provides a point of difference, and a potential competitive edge for gantenerumab as subcutaneous administration could allow for at-home administration. However, there are still challenges for gantenerumab if it is to succeed as an AD treatment.

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In general, with amyloid-based therapies there are concerns regarding the development of amyloid-related imaging abnormalities (ARIAs), therefore, long-term safety results from ongoing Phase III trials will be important for gantenerumab’s success.

Additionally, previous clinical trial failures have cast some doubt over the efficacy of gantenerumab. However, this does not mean that gantenerumab will fail to reach the market, following the precedent set by the FDA with the approval of Aduhelm.

Source: Medindia

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