For over a year, Biogen has been endeavoring to move past the controversies surrounding its drug Aduhelm and shift its focus to its more recent Alzheimer’s medication, Leqembi, which it developed in partnership with Eisai. However, a recent decision from the US Court of Appeals for the First Circuit has thrown a wrench into these efforts.
Last year, Biogen successfully had an investor lawsuit related to its disclosures regarding Aduhelm research dismissed. Now, the appeals court has partially reversed that decision, honing in on a statement made by Biogen’s former chief medical officer, Al Sandrock.
The contentious statement came during Biogen’s second-quarter earnings call in 2020 when Sandrock asserted, “You really need to get to the higher dose,” and added, “I think our data are all consistent with that.” The court dubbed this the “all data” statement and carefully analyzed its context.
To provide some context, in March 2019, Biogen announced the discontinuation of two pivotal trials for Aduhelm based on findings from an independent data monitoring committee’s futility analysis. Later in the same year, Biogen stated that its own analysis and discussions with the FDA supported its decision to seek approval for the drug. A series of public statements followed, and the investors behind the lawsuit alleged that Biogen had not been entirely forthcoming about all the data related to aducanumab as it pursued FDA approval.
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At the time, Biogen had claimed that one of the drug’s pivotal trials, Emerge, had met its primary endpoint in reducing clinical decline. The company believed that a subset of data from patients who received a high dose of the drug supported this conclusion.
The appeals court’s ruling suggests that the investor lawsuit has valid grounds, as it “plausibly alleges” that not all the data supported the company’s argument about a dose-response correlation. It pointed out that “some patients did better on a lower dose, and others experienced the same lack of clinical benefit whether they were on the higher dose or not.”
With this decision, the case may proceed to litigate this single statement from Sandrock.
Aduhelm, despite its controversial FDA approval in 2021, faced considerable challenges due to doubts from payers regarding its efficacy and the quality of the data.
Nonetheless, Biogen finds itself in a different position today. The company has a new CEO, Chris Viehbacher, and is actively engaged in the launch of Leqembi, its Alzheimer’s disease drug. Additionally, it recently acquired Reata and the promising Skyclarys.
Al Sandrock has since moved on from Biogen and now leads Voyager Therapeutics, leaving the company to navigate the complexities of its past while forging a path forward in the ever-evolving landscape of Alzheimer’s disease treatments.
