Data from the study were mixed (with one endpoint met and one missed) and semorinemab has previously failed to hit the mark in a Phase II study of patients with prodromal-to-mild Alzheimer's disease.
Lack of efficacy in earlier-stage patients may not be a red flag, but it is hard to tell at this stage.
“The dynamics of Alzheimer's disease typically start with amyloid pathology, and after that the tau pathology picks up speed and creates the synaptic disruption. So maybe the later-stage population is more sensitive to tau-related mechanisms in a shorter timeframe.”
JAKs boxed in
Following on from new FDA safety guidance for all JAK inhibitors as treatments for rheumatoid arthritis, the drug class could be "irreparably damaged" by the agency's new labelling requirements, says one expert in the field.
Snap-polls we fielded to rheumatologists and dermatologists give an indication as to how much of an impact new safety guidance will have for the JAKs in rheumatoid arthritis and atopic dermatitis respectively.
Can Farxiga follow Jardiance?
Eli Lilly and Boehringer Ingelheim's Jardiance is poised to become an important new therapy option for a group of harder-to-treat heart failure patients, which could result in a billions of dollars in additional revenues.