Biogen’s Alzheimer’s drug is unlikely to receive EU approval.

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Biogen’s Alzheimer’s drug is unlikely to receive EU approval.

Drug maker Biogen said on Wednesday that a panel of drug critics in the European Union had indicated that its new Alzheimer’s drug was unlikely to be approved there, the latest blow to a drug that has been mired in controversy as it has been approved. was given. United States in June

Biogen said a committee of experts advising the European Medicines Agency had issued a “negative trend vote” — an early indication that usually precedes a recommendation that the drug is not approved — this month. On the company’s application for, Eduhelm. The panel will formalize its recommendation at a meeting next month.

The company’s interim head of research, Dr. Priya Singhal, said Biogen was “disappointed” with the panel’s vote. Biogen said in a statement that it would continue to work with EU regulators “as it considers next steps” 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 advisors and several Alzheimer’s experts, who believed it to show There was not enough evidence that Eduhelme is effective.

In one study that found positive results, a higher dose of the drug only moderately slowed degradation. Typically mild but potentially serious side effects such as brain swelling or bleeding occurred in 40 percent of clinical trial participants.

Biogen debuted the drug with an average $56,000 annual price tag, fueling hopes it would hit government budgets within a few years. But the drug has had a surprisingly slow start in the first few months of commercial availability. The company reported that the drug brought in just $1.9 million in revenue from the time it became available in the United States in June until the end of September.

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In the United States, the federal agency that administers Medicare is reviewing whether to standardize drug coverage across the country, a move that could restrict which patients receive it. A draft decision is expected in January, with a final decision by April.

The company announced on Monday that its head of research, who supported internal efforts to develop EduHelm, Al Sandroc, would be retiring from the company at the end of the year.

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