A few days ago, news showed that European regulators did not intend to repeat the mistakes of the US FDA to avoid falling into a controversial situation caused by the approval of Biogen and Eisai's Alzheimer's disease drug Aduhelm.

Bojian said that it has received a "negative trend vote" from the European Medicines Agency's Committee on Medicines for Human Use (CHMP) on Aduhelm's application. For Bojian, as an analyst has seen, if Aduhelm's European regulatory results are not as expected, then 40% of the drug's potential revenue will face the result of loss. During the review process, trend voting will directly affect the opinions of European CHMP expert members on drug applications. According to the European EMA guidelines, although trend voting only records the informal positions of review experts, unless more important new information is provided, the final official voting results may not change.

The preliminary negative opinion means that European drug reviewers believe that Aduhelm should not be approved for the treatment of Alzheimer's disease. The decision was made after an oral hearing held last week, and a formal ruling is expected at the next European CHMP meeting in December this year. In addition to the EU market, Bojian and Eisai are also actively seeking breakthroughs in the Asian market. Japanese regulators may make a decision based on the documents submitted in December 2020 before the end of this year.

Royal Bank of Canada Capital Markets analyst Brian Abrahams wrote in a report on Wednesday that regulatory setbacks in the European market will cut Aduhelm's future potential revenue by 40%. The company also stated in a statement that Bojian will continue to have close communication and contact with European EMA and CHMP on the next development of Aduhelm in Europe.

Abrahams pointed out that Biojian can appeal the European CHMP proposal, but the success rate of this strategy has historically been low, only about 20%. In view of the existing data set of the drug and the controversy since the drug was launched in the United States, Abrahams does not expect that Aduhelm will eventually pass the European regulatory agency. Abrahams added that even with approval, reimbursement for the drug may be challenging given the high price of the drug. The price of Aduhelm in the United States is approximately US$56,000 per year. Since it was approved by the US FDA for marketing, the drug has been priced high because it has no clear effect and has caused a sensation in the United States.

Bojian has experienced a difficult period since the drug was unexpectedly approved by the US FDA in June. Echoing the overwhelming negative opinions of the external FDA advisory committee on the therapy, clinicians generally have reservations about the use of the drug. According to data, Aduhelm's sales in the third quarter of this year were only $300,000.

However, Bojian insisted that the drug has a clear effect. At the Alzheimer's Disease Clinical Trials Conference last week, the company announced more biomarker data from Aduhelm. The results show that this anti-amyloid beta drug can also reduce the blood level of phosphorylated tau, and beta amyloid plaques and tau tangles are two signs of Alzheimer's disease. Although the company described the reduction of p-tau as a "correlation" with cognitive improvement, the correlation value is actually very low.

In addition, the drug has also suffered repeated setbacks in medical insurance cooperation. In August of this year, the Department of Veterans Affairs decided to exclude Aduhelm from its formulary. The Centers for Medicare and Medicaid Services (CMS) is expected to make a ruling on how to pay for medical insurance for Aduhelm early next year.

In addition to the high price of Aduhelm and the unwarranted effect, the drug even faces safety risks. According to the recent update of the U.S. FDA's adverse event reporting system, some patients died after using the drug, which further aggravated people's suspicion of Aduhelm. A 75-year-old woman in Canada died after being diagnosed with brain swelling or amyloid-related imaging abnormalities, which is only a known side effect of Aduhelm.

Reference source: Biogen’s Aduhelm, already battling US skepticism, faces likely European rejection