Aduhelm Becomes First New FDA-Approved Alzheimer’s Therapy Since 2003

Aduhelm Becomes First New FDA-Approved Alzheimer’s Therapy Since 2003

June 7, 2021 – The U.S. FDA has granted accelerated approval to Aduhelm ^TM (aducanumab), manufactured by Biogen, to treat Alzheimer’s disease. Aduhelm is a first-in-class treatment for Alzheimer’s disease, the first new FDA-approved Alzheimer’s therapy since 2003, and the first FDA-approved therapy to target the condition’s pathophysiology (disordered physical functions associated with disease or injury). Continued approval for this indication may be contingent on verification of clinical benefit in confirmatory trials.

Alzheimer's disease is the most common form of dementia and the sixth leading cause of death in the United States. It disrupts communication between neurons in the brain, affecting memory, thought, and behavior. One of the physical changes observed in the brain of patients who have Alzheimer’s includes the formation of amyloid beta plaque, an abnormal accumulation of amyloid beta protein that interferes with proper neuron function and may be tied to the clinical decline of patients.

According to the FDA, patients who received Aduhelm in clinical trials experienced significant dose- and time-dependent reduction of amyloid beta plaque, while patients in control arms saw no amyloid beta plaque reduction. Trial participants had been diagnosed with early-stage Alzheimer’s disease causing mild cognitive impairment and mild dementia, and had amyloid pathology confirmed by positron emission tomography (PET) imaging.

Aduhelm requires dose titration for the first six infusions under the recommended dosing. The recommended maintenance dose is 10mg/kg of the patient’s body weight. Aduhelm is administered via 60-minute intravenous infusion once every four weeks, with each infusion occurring at least 21 days apart. Patients should have had brain magnetic resonance imaging (MRI) within one year prior to initiating treatment, and additional MRIs should be obtained prior to a patient’s first maintenance dose and sixth maintenance dose to monitor for microhemorrhages and amyloid-related imaging abnormalities.

Biogen has launched Aduhelm at a wholesale acquisition cost (WAC) of $56,000 per year.