Athira Pharma CEO Leen Kawas accepts the award for CEO of the Year at the 2019 GeekWire Awards. (GeekWire Photo / Kevin Lisota)

The approval on Monday of the first new drug for Alzheimer’s disease in nearly two decades — Biogen’s aducanumab — helps shine a light on a path forward for other companies developing Alzheimer’s therapies, including Seattle-based Athira Pharma, which saw its stock rise more than 4% off the Biogen news.

The FDA cleared aducanumab (also known as Aduhelm) on an accelerated, conditional approval program, and is requiring the company to conduct a new clinical trial to test effectiveness while it markets the drug. Approval came despite the near-unanimous objection of the agency’s independent advisory committee that there was not enough evidence that the drug had a significant patient benefit.

The FDA’s accelerated approval program is designed to advance therapies for a serious condition that is not addressed adequately by available therapies. Criteria include that the therapy “generally provides a meaningful advantage over available therapies and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit,” according to the FDA.

That the FDA deployed this framework suggests that it may similarly ease the approval …read more

Source:: GeekWire


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