Following weeks of fiery criticism for its wide-labeled approval for Biogen’s Aduhelm for anyone with Alzheimer’s disease, the FDA is now narrowing the recommended window of patients to only those with milder forms of the memory-robbing disease.
Biogen on Thursday said the FDA approved an updated label for Aduhelm, also known as aducanumab, that recommends the amyloid-beta targeting antibody for people with mild cognitive impairment or mild dementia, aligned with those included in Biogen’s late-stage trials.
The FDA warns that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”
RELATED: Biogen’s shockingly broad Aduhelm label—and $56K price—set up a $10B launch, analysts say
Biogen requested the update based on “ongoing conversations with prescribing physicians, FDA and patient advocates,” research head Alfred Sandrock, Jr., M.D., Ph.D., said in a statement. The goal is to “further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval,” Sandrock added.
The slimmed approval follows the FDA’s decision to award Aduhelm an “almost shockingly broad” label, as some analysts put it, in early June, essentially giving Biogen free reign to the estimated 6 million Alzheimer’s patients living in the U.S.
Intense pushback followed as market watchers pointed out that the drug could overwhelm payer budgets, particularly Medicare, which covers most Alzheimer’s patients in the U.S.
Although Biogen’s label update comes just over a month since Aduhelm’s initial approval, it follows a string of stinging rebukes, including from high-ranking lawmakers, against the Cambridge-based drugmaker.
On Capitol Hill, Biogen has faced criticism over its $56,000 per year list price for Aduhelm, the only approved drug intended to slow the progression of the disease. In some estimations, given the FDA’s expansive go-ahead, Aduhelm could eventually balloon Medicare’s spending above the cost of all current Part B drugs.
RELATED: Congressional Democrats launch probe into Biogen’s Aduhelm FDA approval, citing ‘serious concerns’
That’s all for a drug that has shown murky clinical benefits, at best, critics argue. Both Biogen and the FDA are now the subjects of a Congressional probe, spearheaded by the House Committee on Oversight and Reform, over the company’s pricing tactics, as well as the FDA’s approval process.
As more details surrounding Aduhelm’s approval come to light, prominent Democratic lawmakers have targeted the FDA’s dealings with the drugmaker initiated well before the treatment was cleared in June. In a letter to the HHS on Tuesday, Rep. Katie Porter, D-California, charged Biogen with “undue influence” over the FDA’s review process.
