Doctors Frustrated By Lack Of Guidance On Who Should Get Aduhelm
Broad Label Has No Requirement To Test For Amyloid
Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.
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With accelerated approval granted and a supplemental filing for full approval in the FDA's hands, Eisai set a price it says is below the “societal value” its Alzheimer’s drug provides as it prepares to seek Medicare coverage. Labeling notably comes with no black box warning or safety restrictions despite various concerns.
The US FDA accepted an application for accelerated approval and set a 6 January action date, giving lecanemab ample time to reach the market ahead of Lilly’s competing anti-amyloid antibody donanemab.
Biogen caught a lucky break in getting the first FDA approval for a potentially disease-modifying Alzheimer’s therapy, but doubt over clinical benefit and commercial missteps have left Biogen in a precarious position a year later.