The biotechnology company Biogen Abandon Aduhelmits questionable Alzheimer’s disease drug that has struggled on the market since its scandal-plagued regulatory approval and eyebrow-raising pricing in 2021.
The company announced Wednesday that it is terminating the license for Aduhelm (aducanumab) and halting all development and commercialization activities. Rights to Aduhelm will revert to Newrimune, the Swiss biopharmaceutical company that discovered it.
Biogen also plans to complete ENVISION, a Phase 4 clinical trial required by the Food and Drug Administration to prove Biogen’s claim that Aduhhelm is effective in slowing the progression of Alzheimer’s disease in its early stages. This could not be achieved reliably in two phase 3 clinical trials.
In its announcement, Biogen noted that it needed to take a $60 million financial hit in the fourth quarter of 2023 to conclude the Aduhhelm study, but Biogen reportedly at one point It was estimated that the same amount of profits would be generated. Annual revenue is $18 billion.
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However, the data did not support such lofty aspirations. The drug aims to act on clumps of misfolded beta-amyloid protein that accumulate in the brains of Alzheimer’s patients. An early small clinical trial showed the drug could reduce plaques in the brains of Alzheimer’s patients, but it initially failed two identically designed Phase 3 trials. It became. The trial, which enrolled about 3,300 patients in total, aimed to assess whether the drug could slow the progression of Alzheimer’s disease in its early stages.
In March 2019, the company announced it was ending both trials after a futility analysis found the drug was ineffective. But later that year, Biogen made a surprising about-face, announcing that additional data was coming in from trials that followed the March announcement. A new analysis of data from one of the two trials found that while some patients receiving the highest dose showed a small benefit on cognitive tests, patients in the other trial still showed no benefit. It was shown that it was not seen. The data also found that 40% of patients who received the high dose developed brain swelling.
Biogen boldly submitted data to the FDA for approval. In November 2020, the FDA’s independent advisory committee overwhelmingly voted against Aduhhelm’s approval. Ten of the 11 committee members voted against the drug, while the remaining committee members voted “unsure.” After voting no, one member commented on the “discrepancy” between Biogen’s presentation of the drug and the actual data. “It feels like the audio and video on the TV are out of sync. There are literally over a dozen red threads that suggest concerns about the integrity of the evidence,” the member said. In its own statistical analysis of the data, the FDA concluded that “there is no convincing and substantial evidence that the treatment is effective or slows disease progression.”
