Biogen’s aducanumab casts doubts about its approval from federal regulators

Following the new clinical trial results of Biogen’s aducanumab (5th December 2019) presented at the 12th Clinical Trials on Alzheimer’s Disease (CTAD);

Alessio Brunello, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“Biogen has raised skepticism and criticism for how the data from the two aducanumab trials, ENGAGE and EMERGE, were analyzed and for the decision in October to seek approval of the drug by the Food and Drug Administration (FDA). The new data, presented at the CTAD conference, did not show any new results from the data released by Biogen in October, however the company will proceed with a new drug application (NDA) for the drug in early 2020 as it was previously anticipated.

“The data from the EMERGE study were positive with convincing clinical efficacy with the high-dose arm, however, the ENGAGE study did not show the same pattern of target engagement or clinical efficacy. Key opinion leaders (KOLs) interviewed by GlobalData expressed mixed opinion about the potential approval from FDA as its standard of approval is substantial evidence of efficacy and the cumulative data for aducanumab are not really exhaustive to meet this standard. However, they are unlikely to turn down aducanumab even if its benefit is modest, given the lack of any therapy that is truly efficacious.

“GlobalData expected global sales of the drug to be high equating to $4,686m of sales in 2026 in the seven major markets (7MM*), as there are no disease modifying drugs for this indication. The potential approval for aducanumab is not likely to be the final treatment for Alzheimer’s disease (AD) but it could open doors for combination research, namely anti- Aβ therapies with anti tau-therapies. Combination therapy is likely the way to go for the amyloid beta inhibitor treatment class, but until a drug is approved, combination research cannot be explored. The approval could also encourage companies with other amyloid-based therapies that failed before to continue testing and attract investors to raise money into the research.

“KOLs interviewed by GlobalData were consistently enthusiastic about aducanumab’s potential and identified it as the most promising drug in the AD pipeline, however its infusion route of administration could be an issue where infusion centers aren’t available and concerns regarding the developing of Amyloid Related Imaging Abnormalities (ARIA) can represent a barrier for the uptake for aducanumab. Experts in the field agreed that the drug actually works to clear amyloid plaques in the brain however, they expressed doubts about its approval from federal regulators, even though the FDA could decide to approve the treatment due to the significant unmet needs in this disease area where no drug has been approved in the past 17 years.”

*7MM = US, France.Germany,Italy, Spain, UK, Japan

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