The FDA approved an updated label for intravenous aducanumab to clarify which patients with Alzheimer’s disease (AD) should receive the drug.
The original accelerated approval granted in early June did not specify who was best suited to receive aducanumab and broadly indicated the drug to treat any patients with AD, an omission that raised questions regarding the best patient-selection approach for physicians prescribing the drug. Now, in this updated label, the FDA indicated that aducanumab should only be initiated in “patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.”
To date, there are no safety or efficacy data on initiating treatment at earlier or later stages of AD than were studied in clinical trials, the agency added.
“Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three [aducanumab] clinical trials that supported approval,” Alfred Sandrock, Jr., MD, PhD, Head of Research and Development at Biogen, the drug’s manufacturer, explained in a company press release. “We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”
While this update to aducanumab’s prescribing information answers one important question, a number of questions remain regarding the controversial approval—not the least of which is whether the drug is actually effective enough to warrant approval, or whether the drug’s ability to reduce amyloid beta plaques in the brain actually translates to improved clinical outcomes in AD, as G. Caleb Alexander, MD, MS, from the Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine in Baltimore, Maryland, and Jason Karlawish, MD, from the University of Pennsylvania, Philadelphia, recently argued in Annals of Internal Medicine.
The question of efficacy is made even more important when considering the hefty $56,000 projected list price of the drug, totaling an annual price tag of $56 billion if the drug is prescribed at the levels indicated by the manufacturer—a sum that many experts believe would be better used elsewhere, according to reporting by Kaiser Health News.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 33
Topic ID: 82,33,485,730,33,192,725,925
