Remove tag amyloid
article thumbnail

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

Drugs 110
article thumbnail

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. A positive result on the test indicates a high likelihood of amyloid presence, as confirmed by amyloid PET scans or cerebrospinal fluid (CSF) testing.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The FDA and Aduhelm: WTF?

World of DTC Marketing

Not to mention the $56,000 annual price tag. While it’s not clear that Aduhelm actually slows down Alzheimer’s, there was “convincing evidence” that it had a “robust” effect on amyloid plaques. OK the amyloid hypothesis has never been universally accepted or proven.

Drugs 218
article thumbnail

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

The disease is characterized by the accumulation of amyloid beta plaques and neurofibrillary, or tau, tangles in the brain that result in loss of neurons and neural connections. Aducanumab is a human IgG1 monoclonal antibody that binds to aggregated forms of amyloid beta to help reduce its buildup. Aducanumab Controversy and Price Tag.

Drugs 98
article thumbnail

FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism

XTalks

The FDA’s approval of Biogen’s Alzheimer’s drug about a month ago on June 7 sparked harsh criticism because although the drug has been shown to reduce amyloid beta plaques in the brain (a surrogate endpoint), there was no clear associated clinical benefit. head of research and development at Biogen, in a statement from the company.

Drugs 98
article thumbnail

Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice).

article thumbnail

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

pharmaphorum

The FDA awarded a fast-track designation to lecanemab in December and has also given the drug breakthrough tag as a treatment for early-stage Alzheimer’s, and Biogen and Eisai will be hoping the drug can sidestep the controversy that engulfed Aduhelm from the moment it was approved.