Biogen’s sales for its new Alzheimer’s drug fell short of Wall Street expectations, with the drugmaker reporting on Wednesday that it brought in millions less than anticipated from aduhelm in the third quarter.
The first Alzheimer’s drug approved by the Food and Drug Administration (FDA) in almost two decades yielded $300,000 for Biogen between July and September after forecasts had predicted revenue to reach $12 million.
Since the FDA’s “accelerated approval,” aduhelm has been immersed in controversy as Biogen sought a $56,000 annual price for the drug and amid several insurers’ and physicians’ uneasiness over the minimal data showing effectiveness.
In a statement, Biogen CEO Michel Vounatsos said aduhelm’s uptake is “delayed” but “we continue to believe in its long-term potential.” He said on a conference call that Biogen was “not panicking” about the missed expectations, according to news reports.
Stat News had previously reported last month that uptake for aduhelm was lower than expected, with slightly more than 100 patients as of Sept. 11.
With its approval, the FDA strayed from its advisory panel’s near-unanimous rejection of aduhelm, and a few members of the committee later resigned. Two House committees have launched investigations into the FDA’s decision, and acting FDA Commissioner Janet Woodcock requested a federal probe into the approval process.
In response, medical centers like the Cleveland Clinic and Mount Sinai Health System declared they would not administer aduhelm, and the Department of Veterans Affairs and other insurers did not put the Alzheimer’s drug on their VA National Formulary.
The federal agency had based its decision on whether it effectively decreases the brain plaque thought to contribute to Alzheimer’s, instead of direct evidence demonstrating the drug could help slow the disease.
The high annual price for aduhelm has sparked worries among experts about how the drug will affect Medicare spending. The Centers for Medicare & Medicaid Services started a review to decide whether to standardize coverage for aduhelm, with a draft decision slated for January and a final determination scheduled for April.