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Back to School 2021
Stretching the vision of accelerated approval
BY C. SIMONE FISHBURN, EDITOR IN CHIEF
At some snapshots in time, one issue bubbles to the surface, demanding attention and solutions to problems that have been simmering for years.
Right now, that issue is accelerated approval.
BioCentury’s 29th Back to School project examines the future of accelerated and conditional approvals globally, and stretches the vision of what these pathways could achieve.
FDA’s accelerated approval pathway, introduced in 1992, has spawned similar schemes in Europe, Japan, China and the U.K., each of which added nuanced changes but based their pathways on the same idea — granting approval for a drug on the basis of less data than for full approval, to expedite treatments to patients with severe disease and no alternatives, on the condition that data collection will continue postmarket; if the evidence does not uphold the risk-benefit assessment, the drug or an indication can be withdrawn.
The catalyst for the current furor was FDA’s surprising and controversial decision to grant accelerated approval to Aduhelm aducanumab-avwa, the Alzheimer’s therapy from Biogen Inc. (NASDAQ:BIIB). But the issues go far beyond Aduhelm, and far wider than the pathway in the U.S... READ MORE