Is solanezumab FDA approved?

Lilly will not pursue FDA approval for solanezumab in mild AD (see company release). Trial results have been published (Honig et al., 2018; Schwarz et al., 2019). Solanezumab’s safety record and indication of a small benefit in mild AD prompted its selection for two secondary prevention studies.

What is the biological target and mechanism of action of solanezumab?

Mechanism of action Solanezumab is thought to act as an “amyloid beta sink” that is “facilitating flux of amyloid beta from a central to peripheral compartment”. This increases the peripheral elimination of both amyloid beta and the antibody.

How much is Donanemab?

Total health care sector and societal costs increased by $130 100 and $127 800, respectively, with aducanumab and by $78 700 and $71 600, respectively, with donanemab, driven largely by drug costs ($119 000 for aducanumab and $44 600 for donanemab).

Who makes solanezumab?

Solanezumab is Lilly’s phase 3 monoclonal antibody being studied as a potential therapy for people with mild cognitive impairment due to Alzheimer’s disease (EXPEDITION-PRO), preclinical Alzheimer’s disease (Anti-Amyloid Treatment in Asymptomatic Alzheimer’s “A4”), and Dominantly Inherited Alzheimer’s Disease (“DIAN”).

Is Aducanumab available?

On June 9, 2022, Biogen announced it will withdraw its submission of aducanumab from regulatory review by Health Canada as a treatment for people living with early stages of Alzheimer’s disease.

How does Gantenerumab work?

Gantenerumab preferentially interacts with aggregated brain Aβ, both parenchymal and vascular. The antibody elicits phagocytosis of human Aβ deposits in AD brain slices co-cultured with human macrophages. It also neutralizes oligomeric Aβ42-mediated inhibitory effects on long-term potentiation in rat brains.

What is the biological target of solanezumab?

Solanezumab is a biological drug that targeted amyloid protein, a signature of Alzheimer’s disease, and was designed to break up the clumps of amyloid in the brain.

Is donanemab better than aducanumab?

Donanemab’s amyloid-lowering ability is not in dispute. In Trailblazer-Alz, it lowered amyloid-β levels on average by almost 80%. These data suggest that it outperforms aducanumab on amyloid clearance.

Is donanemab FDA approved?

In June 2021, the FDA granted donanemab Breakthrough Therapy designation, to speed development and review. Lilly submitted a licensing application in October 2021, under the same accelerated approval pathway used for aducanumab, with rolling submission of trial data (press release).

Is gantenerumab FDA approved?

In October 2021, the FDA designated subcutaneous gantenerumab a Breakthrough Therapy, offering an accelerated review and approval process.