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Biogen's Alzheimer's disease drug Aduhelm's European marketing application may be rejected

 Last Update: 2021-12-06
 Source: Internet
 Author: User

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A few days ago, news showed that European regulators did not intend to repeat the mistakes of the US FDA and 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

The preliminary negative opinion means that European drug reviewers believe that Aduhelm should not be approved for the treatment of Alzheimer's disease

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%

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%

Bojian has experienced a difficult period since the drug was unexpectedly approved by the US FDA in June

However, Bojian insisted that the drug has a clear effect

In addition, the drug has also suffered repeated setbacks in medical insurance cooperation

In addition to the high price of Aduhelm and the unwarranted effect, the drug even faces safety risks

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