The study was intended to recruit 6,000 Alzheimer’s patients, but even after recruiting had proceeded for seven months, just 29 patients were enrolled. As a result, the trial was cancelled, and the aforementioned shutdown was only a small wrinkle in a much larger controversy.
PharmaLive recently reported that Aduhelm (aducanumab-avwa) was approved by the FDA in June of 2021. This made it the first Alzheimer’s therapy to receive FDA approval in over twenty years.
Biogen, in collaboration with Eisai, had actually abandoned Aduhelm in March 2019. At that time the companies discovered that Aduhelm would not meet its endpoints. But after several trials, analyses, and conversations with the FDA, the Phase III trial did meet the primary endpoint when Aduhelm’s highest dose was administered. However, the controversies continued.
In November 2020, the FDA’s Peripheral and CNS Drug Advisory Committee voted not to approve the drug; however, the FDA approved it nevertheless using accelerated approval. The FDA based its approval on data that showed that Aduhelm removed beta-amyloid in patients.
Special attention must be given to the fact that Aduhelm is associated with possibly fatal side effects. Specific imaging irregularities that were amyloid-related could trigger cerebral edema and death.
Biogen announced the termination of the Aduhelm study in ClinicalTrials.gov. In April of this year, the U.S. CMS issued guidance for Aduhelm that put a limit on its availability. The guidance allows reimbursement for the drug only under the condition that it is being used in clinical trials.
The same guidance will apply to beta-amyloid-clearing drugs that are slated to be submitted to the US Center for Medicare and Medicaid Services (CMS) for approval.
Aduhelm’s Underperformance
Aduhelm’s sales in the fourth quarter ($1 million) were substantially below projections ($10.79 million). Biogen responded by cutting its price from $56,000 for each patient to approximately $28,000 per patient for the entire year.
Eisai, based in Tokyo, left its Aduhelm partnership with Biogen in March of 2022. Eisai will no longer receive worldwide profits or losses but will receive royalties in accordance with annual sales.
However, Biogen is continuing to conduct the ENVISION Phase IV clinical trial in order to confirm the FDA’s accelerated approval of Aduhelm. The companies anticipate approximately 1500 patients who have been diagnosed with early Alzheimer’s and beta-amyloid causation to enroll.
Results are expected in the second quarter of 2026 if sufficient enrollment is achieved.
Lecanemab, another Alzheimer’s drug, is currently being developed by Eisai and Biogen with Eisai having the right to final decisions.
