Biogen, Inc.’s Phase IV post-marketing confirmatory trial of Aduhelm for the treatment of Alzheimer’s disease is on track to begin enrolling patients in May 2022 with the expectation that data will be available in 2026 – once again raising questions about why FDA originally specified such a lengthy timeline for confirming the accelerated approval.
The plan outlined by Biogen means patients, physicians and payers will have to wait at least four years to see...