WASHINGTON — The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug for every single patient with the disease surprised even top FDA officials involved in deliberations about the approval process, two senior staffers told STAT.
One of the sources went further, saying they would never have supported the faster approval process that the FDA employed had they known the agency was considering such a broad patient population.
The staffers — who were high-ranking enough to be included in a small April 26 meeting intended to discuss the accelerated approval path — did not know even in late April that the drug’s target population would ultimately be so broadly defined, they said. Biogen, which makes the drug, had only studied its effects in a far smaller population of people in the early stages of the disease.
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