Biogen's Alzheimer's disease drug is unlikely to gain EU approval.

The drug maker Biogen said wednesday that a panel of drug reviewers in the European Union had indicated that its new Alzheimer’s drug w...


The drug maker Biogen said wednesday that a panel of drug reviewers in the European Union had indicated that its new Alzheimer’s drug was unlikely to be approved there, the latest setback for a drug that has been mired in controversy since its inception. approval in the United States in June.

Biogen said an expert committee advising the European Medicines Agency had issued a “negative trend vote” – a preliminary signal that usually precedes a recommendation to not approve the drug – at the request of the company for the drug, Aduhelm, this month. The panel will formalize its recommendation at a meeting next month.

The company’s acting head of research, Dr Priya Singhal, said Biogen was “disappointed” with the panel’s vote. Biogen said in a statement it would continue to work with European Union regulators “as it considers the next steps” to try to get the drug approved in Europe.

In the United States, the Food and Drug Administration approved the drug despite conflicting clinical trial results and objections from its own independent advisers and many Alzheimer’s disease experts, who believed there was no not enough evidence to show that Aduhelm is effective.

In a positive study, a high dose of the drug only modestly slowed the decline. Usually mild but potentially serious side effects, such as swelling of the brain or bleeding, occurred in 40% of clinical trial participants.

Biogen introduced the drug with an annual price of $ 56,000, on average, fueling expectations that it would strain government budgets within a few years. But the drug got off to a surprisingly slow start in its first months of commercial availability. The company said the drug generated just $ 1.9 million in revenue between when it became available in the United States in June and the end of September.

In the United States, the federal agency that administers Medicare is examining whether to standardize coverage for the drug nationwide, a step that could restrict the patients who receive it. A draft decision is expected in January, with a final decision in April.

The company announced Monday that its head of research who had championed the internal effort to develop Aduhelm, Dr Al Sandrock, would step down from the company at the end of the year.

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Newsrust - US Top News: Biogen's Alzheimer's disease drug is unlikely to gain EU approval.
Biogen's Alzheimer's disease drug is unlikely to gain EU approval.
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