pharmaphorum

DECEMBER 24, 2021

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.

FDA 110

FDA 110

PharmaShots

APRIL 28, 2023

Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.

FDA 56

FDA 56

PharmaShots

MARCH 31, 2023

PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer Date: Mar 31, 2023 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, Head, Neck Cancer, Clinical Trial, P-III, VERSATILE-003 Trial Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular (..)

FDA 40

FDA 40

pharmaphorum

MAY 10, 2022

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.

FDA 40

FDA 40

pharmaphorum

JUNE 8, 2021

ICER argues that Aduhelm was effectively approved on the strength of a biomarker – removing amyloid from the brain – rather than clinical outcomes, which is “puzzling” as other drugs have been shown to remove amyloid from the brain yet failed to help patients. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021.

FDA 98

FDA Labelling 98

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

FDA 52

FDA 52

pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

Insurance 121

Insurance FDA 121