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... and here is Woodcock's defense.

Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals

https://endpts.com/woodcock-defends-biogens-new-alzheimers-drug-says-it-has-more-supportive-data-than-many-past-accelerated-approvals/

Zachary Brennan
Senior Editor
Acting FDA commissioner Janet Woodcock publicly defended Biogen’s controversial Alzheimer’s drug Aduhelm on Tuesday, saying it’s “a very solid” accelerated approval, and “has a lot more supportive data” than many other drugs that have won accelerated approval over the years.

While Woodcock did not delve into which past accelerated approvals had less supportive data than Aduhelm, she did acknowledge some “process problems” with the Aduhelm approval, noting that the advisory committee did not vote against Aduhelm being approved under the accelerated pathway. But she stopped short of mentioning that the committee was never asked to consider an accelerated approval, and multiple FDA officials assured the adcomm panelists that an accelerated approval wasn’t in the cards.

“This is a solid approval, the performance of the surrogate was very strong in multiple trials. What people complain about is the correlation with the clinical outcome of interest, and you’ll see the analyses were very solid,” she said at the USA-India Chamber of Commerce’s virtual meeting.

Woodcock, who compared the Aduhelm approval to the approval of early HIV drugs, also acknowledged other drugs that lower beta amyloid could be approved based only on biomarker data via the accelerated approval pathway.

“It certainly would be possible. People have to look at the memos, there’s an issue of magnitude, and there’s an issue of exposure response on the surrogate and then the correlation of exposure on the slowing of cognitive decline,” Woodcock said.

But Aduhelm is not without its liabilities, Woodcock said, noting that the side effect of ARIA is related to the pharmacodynamic effects of the drug.

She maintained that FDA is not lowering the bar for drug approvals with this recent decision, saying she’s “heard that for 30 years.” She also called for more of a “totality of evidence” approach to deciding on whether drugs should be approved, noting that there shouldn’t be just one way to approve drugs.

“Fundamentally, at some point, the 50-year investment in basic science has to merge with clinical methodology and we have to just stop thinking empirical evaluation is the only way of evaluating truth,” Woodcock said.

AUTHOR
Zachary Brennan