Biogen's Aduhelm, already battling US skepticism, faces likely European rejection

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Biogen is also eyeing the Asian market and will continue EMA and CHMP talks regarding Aduhelm next steps in Europe, but even with a European approval, reimbursement would be an uphill battle, noted RBC Capital Markets analyst Brian Abrahams. (Biogen)

European regulators don’t plan to go down the same controversial path as their U.S. counterparts did in approving Biogen’s Eisai-partnered Alzheimer’s disease therapy, Aduhelm. And for Biogen, as one analyst sees it, 40% of potential revenue on the drug is going down the drain.

Biogen has received a “negative trend vote” on Aduhelm’s application from the European Medicines Agency’s (EMA's) Committee for Medicinal Products for Human Use (CHMP).

A trend vote takes the pulse of CHMP members for their opinions on a drug application during the review process. While a trend vote records the informal position of reviewers, the final formal vote likely won’t change unless major new information is provided, per EMA guidance.

The preliminary negative opinion means the European drug reviewers believe Aduhelm shouldn’t be approved. It followed an oral hearing held last week, and a formal ruling is expected at the next CHMP meeting in December.

In addition to EU, Biogen and Eisai are also eyeing the Asian market, with a possible decision from Japanese regulators this year based on a filing in December 2020.

RELATED: Sandrock makes a sharp exit, retiring as Biogen R&D chief amid fallout from Aduhelm approval

A European rejection would still effectively wipe away 40% of potential future Aduhelm revenue, RBC Capital Markets analyst Brian Abrahams wrote in a Wednesday note.

Biogen will continue to engage with the EMA and CHMP regarding next steps for Aduhelm in Europe, the company said in a statement.

Biogen can appeal CHMP’s recommendation, Abrahams noted, but the success rate with such a strategy has historically been low at about 20%. With the existing dataset, Abrahams expects Aduhelm will not make it pass the European regulators.

Even in the case of an approval, reimbursement would have likely been challenging given the drug’s high price, Abrahams added. Aduhelm’s U.S. price, at about $56,000 per year, has already struck a nerve at home.

Biogen has had a hard time since the surprising FDA go-ahead in June. Echoing the overwhelmingly negative opinion from an external FDA advisory committee, doctors have been slow to adopt the antibody drug. Biogen recorded merely $300,000 from third-quarter Aduhelm sales.

RELATED: Biogen's Aduhelm records one patient death. Is the controversial Alzheimer's drug to blame?

The Department of Veterans Affairs in August decided to leave Aduhelm off its formulary. The Centers for Medicare and Medicaid Services is expected to rule on how to cover Aduhelm for Medicare early next year. CMS has already said, though, that it is raising Medicare Part B’s premium by about 15% in 2022, pointing to the Biogen drug as a major driver for the increase.

In a revelation that further fuels doubts about Aduhelm, a recent update from the FDA Adverse Event Reporting System showed a patient death after treatment with the drug. A 75-year-old female in Canada died after she was diagnosed with brain swelling, or amyloid-related imaging abnormality, a known side effect of Aduhelm.

Just as Biogen’s feels the heat of Aduhelm pushbacks, the drug’s key proponent, the company’s lead scientist, Al Sandrock, M.D., Ph.D., is retiring. Priya Singhal, M.D., head of global safety and regulatory sciences, is filling in on an interim basis.

Biogen unveiled more biomarker data for the antibody drug last week at the Clinical Trials on Alzheimer’s Disease conference. The results showed that the anti-amyloid beta drug could also reduce blood levels of phosphorylated tau. Amyloid beta plaques and tau tangles are two hallmarks of Alzheimer’s. Although the company described a “correlation” of p-tau decrease with cognition improvement, the correlation values were low.