As rumblings continued about possible skulduggery between Biogen Inc. and the FDA related to Aduhelm (aducanumab), an already precedent-setting case took yet another turn: Acting FDA Commissioner Janet Woodcock asked acting U.S. Inspector General Christi Grimm’s office to conduct an independent review of goings-on that led to approval of the amyloid-beta-targeting drug in Alzheimer’s disease.
Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s.
The FDA’s recent release of documents related to its accelerated approval of Aduhelm (aducanumab) did little to reduce the controversy surrounding that decision and the U.S. pricing of Biogen Inc.’s Alzheimer’s drug.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
More than two weeks after the FDA gave its go-ahead to Biogen Inc.’s Aduhelm (aducanumab), controversy still rages over the accelerated approval as well as the price for the anti-amyloid beta monoclonal antibody for Alzheimer’s disease (AD). Embattled U.S. regulators made the uncommon move of releasing documents – with more due to be made public later – that show the internal deliberations that led to Aduhelm’s clearance.
Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.
PERTH, Australia – Digital cognitive assessment technology company Cogstate Ltd. saw its stock skyrocket 60% on the heels of FDA accelerated approval of Biogen Inc./Eisai Co. Ltd.’s Alzheimer’s disease drug Aduhelm (aducanumab). Cogstate and Eisai signed a deal in October 2020 that granted Eisai global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate.
As debate continues to rage over the approval and pricing of the Alzheimer’s disease therapy Aduhelm (aducanumab), Biogen Inc. CEO Michel Vounatsos said his firm is “taking a position that is very responsible” but has “yet to be understood out there, and we have to do a better job.”
Biogen Inc. has announced contrasting results from phase III trials of therapies for a rare eye disease and depression, following last week’s controversial FDA approval of Alzheimer’s drug Aduhelm. The Cambridge, Mass.-based firm said a phase III gene therapy study in the rare retinal disease choroideremia missed its primary and secondary endpoints, although the news was better from a potential therapy for major depressive disorder.
LONDON – Controversy over the quality of the data supporting approval of Biogen Inc.’s Aduhelm (aducanumab), and FDA’s requirement for a phase IV study to demonstrate real-world evidence of the effectiveness of the drug, has put the spotlight on the need for better dementia diagnostics, both to stratify trials and to track any reduction in clinical decline.
