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. In a statement, Biogen and Eisai said that the FDA has agreed that Clarity AD “can serve as the confirmatory study to verify the clinical benefit of lecanemab.”

FDA 111

FDA 111

pharmaphorum

OCTOBER 21, 2021

The company’s chief executive Michel Vounatsos said he was “obviously disappointed” with the result, which he maintained resulted mainly from a lack of clarity on reimbursement which has delayed patient access. Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

Insurance 122

Insurance FDA 122

pharmaphorum

MAY 10, 2022

As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of the readout of the confirmatory Clarity AD trial, due in the autumn.

FDA 40

FDA 40

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. This interview has been edited for clarity and length. Currently, all approved CAR-T therapies are autologous, where T cells taken from patients are modified and then re-infused.

FDA 59

FDA Immunization 59