Drug maker Biogen said Wednesday a panel of drug investigators across the European Union had indicated that its new Alzheimer’s drug is unlikely to get approved there, the latest setback for a drug that has been controversial since it was approved in the US will states in June.
Biogen said a committee of experts advising the European Medicines Agency this month issued a “negative trend vote” – a preliminary signal that usually precedes a recommendation not to approve the drug – on the company’s application for the drug, Aduhelm. The panel will formalize its recommendation at a meeting next month.
The company’s interim research director, Dr. Priya Singhal said Biogen was “disappointed” with the panel’s vote. Biogen said in a statement it will continue to work with European Union regulators “while considering 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 results from clinical trials and objections from their own independent advisors and many Alzheimer’s experts who felt there wasn’t enough evidence that Aduhelm was effective.
In one study that gave a positive result, a high dose of the drug slowed the decline only slightly. Typically mild but potentially serious side effects such as brain swelling or bleeding occurred in 40 percent of participants in clinical trials.
Biogen launched the drug at an average annual price of $ 56,000, which raised expectations that it would hit national budgets within a few years. But the drug got off to an amazingly slow start in the first few months of its commercial availability. The company reported that the drug had only grossed $ 1.9 million in sales since its launch in the United States in June through late September.
In the United States, the federal agency that administers Medicare is considering whether to standardize coverage for the drug nationwide, a move that could limit which patients receive it. A draft decision is expected in January and a final decision by April.
The company announced on Monday that its head of research, Al Sandrock, who had advocated Aduhelm’s internal development, would leave the company at the end of the year.