Aduhelm's Journey To Accelerated Approval: Finding Buried Treasure In Uncharted Waters
The Alzheimer’s drug’s regulatory voyage to accelerated approval was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s user fee goal date.
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Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
Find a problem and develop the solution for it: so goes the accepted wisdom for successful health care technology adoption. But as Cognetivity Neurosciences CEO Sina Habibi demonstrates, the reverse can also provide a very valid business pathway.
If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.