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Biogen’s Aduhelm unlikely to get approval in Europe

In another setback for the controversial Alzheimer’s disease antibody, the EMA’s review committee has voted against recommending the treatment


Biogen has expressed its disappointment at the ‘negative trend vote’ for its Alzheimer’s antibody Adhulem (aducanumab) by members of the Committee for Medicinal Products for Human Use (CHMP), which advises the European Medicines Agency (EMA).

The vote is expected to lead to a formal opinion on Biogen’s marketing authorisation application at the next CHMP meeting in December.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Biogen’s interim R&D head, Dr Priya Singhal.

The company will ‘continue to engage’ with the EMA and CHMP while it ‘considers next steps towards the goal of providing access to aducanumab to patients in Europe’.

In the US, where the antibody was approved this summer, Aduhelm is indicated for the treatment of patients with mild cognitive impairment or mild dementia stage of disease. Aducanumab is a monoclonal antibody that has been shown in clinical trials to reduce amyloid beta plaques, a surrogate biomarker that Biogen says is “reasonably likely to predict clinical benefit”.

The news saw the company’s share price drop by 4% in addition to a previous 4% drop the day before after the announcement that its top R&D leader Al Sandrock would leave Biogen at the end of the year.

While Brian Abrahams, an RBC analyst, noted that a failure to launch in Europe will eliminate 40% of Biogen’s potential revenue from the drug, he did not see any ‘direct read-throughs’ to the United States, where Aduhelm has its own problems after a controversial approval process and subsequent poor uptake.

Discussing Biogen’s prospects more widely, Abrahams said its Alzheimer’s franchise was “becoming increasingly dependent” on lecanemab. He continued: “Positive data would provide key validation for the class and enable an entry in the Alzheimer’s space with potential better benefit/risk and an opportunity to price more reasonably; negative data would further damage perceptions around the class and potential [aducanumab] usage.”

Abrahams said the bottom line was that Biogen remained “a company in transition”, with “key risks” to its franchises and future growth drivers.

Rivals in the Alzheimer’s space, primarily Roche and Eli Lilly, are both preparing regulatory filings, with Roche’s leaders talking about a deep discount over the $56,000 price that Biogen charges for Aduhelm in the US.

Article by
Hugh Gosling

18th November 2021

From: Regulatory



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