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Biogen retracts EMA application for Alzheimer's drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation


Following regulatory blocks and rejections late last year, Biogen has decided to withdraw its application for its Alzheimer's drug Aduhelm (aducanumab) in Europe.

The company made the decision to pull its application after discussions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) highlighted that the data provided thus far would not be enough to support a positive opinion on the marketing authorisation of Aduhelm by the regulator.

Biogen’s marketing authorisation had been re-evaluated by the CHMP in response to the company’s request for a reassessment of the negative opinion issued in December 2021.

The EMA had explained that, despite Aduhelm reducing amyloid beta in the brain, the connection between this effect and significant clinical improvement has not been verified.

In December 2021, the EMA raised concerns surrounding the safety of Aduhelm: ‘The studies did not show that the medicine was sufficiently safe as images from brain scans of some patients showed abnormalities (amyloid-related imaging abnormalities) suggestive of swelling or bleeding in the brain, which could potentially cause harm. Furthermore, it is not clear that the abnormalities can be properly managed in clinical practice.’

The EMA had also said Biogen’s data on the drug’s affect on cognition is ‘conflicted’ and, in response to two identical studies carried out on the treatment, the EMA said the results ‘did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease’.

Priya Singhal, head of global safety and regulatory sciences and interim head of R&D at Biogen, said: “We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review.

“We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound.”

In an online statement, Biogen has said that it ‘will continue to advocate for patients and remains committed to research and development, as well as to its collaboration with Eisai, working towards the goal of bringing new treatment options to people living with Alzheimer’s disease’.

Article by
Fleur Jeffries

25th April 2022

From: Regulatory



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