News

Lilly’s Donanemab Granted FDA Breakthrough Therapy Status

The U.S. Food and Drug Administration has named Eli Lilly’s donanemab a breakthrough therapy for treating Alzheimer’s disease, the company announced in a press release. Lilly said it intends to submit a biologics license application or BLA — which would allow it to market donanemab in the U.S.

With New Trial Data, Lecanemab Wins FDA Breakthrough Status

Based on new evidence from an ongoing Phase 2b clinical trial, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to lecanemab, also called BAN2401, an investigational antibody for treating early Alzheimer’s disease. The therapy, being developed jointly by Eisai and Biogen, is designed to…

Gantenerumab Lowers Key Protein Levels in Early-onset Disease Trial

The investigational therapy gantenerumab significantly lowered levels of established biomarkers in a rare, inherited form of early-onset Alzheimer’s disease, despite failing to slow cognitive decline or memory loss in symptomatic and asymptomatic patients, according to data from a Phase 2/3 clinical trial. Based on these results, enrolled patients…

Aduhelm Most Appropriate for Early-stage Alzheimer’s, Experts Say

Aduhelm (aducanumab), approved for Alzheimer’s disease in the U.S., is most appropriate for people with mild cognitive impairment (MCI) due to the disease or early Alzheimer’s dementia, the disorders for which it was tested in clinical trials and subsequently approved, according to experts from the scientific community. The experts…

Gosuranemab Fails TANGO Trial; Biogen Stops Development

Gosuranemab, an investigational antibody against the tau protein, failed to meet its primary and exploratory efficacy goals in the TANGO Phase 2 study, its developer, Biogen, has announced. Now, the TANGO trial has been terminated and Biogen will cease the clinical development of gosuranemab as a potential therapy for…

Mechanisms Behind Anavex 2-73’s Benefits Highlighted in Review

Activation of the sigma-1 receptor or SIGMAR1 — whose production is typically increased with age, but reduced in people with Alzheimer’s disease — drives a series of neuroprotective effects, including the clearance of unnecessary or damaged cellular components, a review study highlights. This supports the therapeutic potential of…

Aduhelm Approved