Biogen Withdraws European Application of Aduhelm

The EMA’s Committee for Medicinal Products for Human Use indicated that the data provided is not sufficient for marketing authorization.

Biogen has withdrawn its marketing authorization application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease. The EMA’s Committee for Medicinal Products for Human Use (CHMP) indicated that the data provided is not sufficient for marketing authorization.

Biogen’s MAA had been under review by the CHMP in response to the company’s request for a re-examination of the negative opinion the regulatory body issued in December 2021.

Aduhelm (aducanumab-avwa) has been a controversial therapy since its FDA approval in June 2021. The approval went against the recommendation of an advisory committee. Clinical trials showed mixed results and Biogen’s pricing for the Alzheimer’s therapy has been what many consider too high based on clinical effectiveness.

The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. Although the trials showed the therapy reduced amyloid plague in the brain, trials where were inclusive of the impact of this on cognitive decline. One study met the primary endpoint, showing reduction in clinical decline, while the second trial did not meet the primary endpoint.

Last year, the Institute for Clinical and Economic Review (ICER) updated its analysis for the drug, stating the price range needed to reach standard cost-effectiveness thresholds is between $3,000 and $8,400 a year, compared with the annual price of $56,000 set by Biogen. December 2021, Biogen lowered its price for Aduhelm to $28,200 per year.

Many insurance companies have refused to cover Aduhelm and CMS early this month finalized its coverage, saying that it will only cover the anti-amyloid monoclonal antibodies for patients who are in clinical trials.

Related: CMS Finalizes Narrow Aduhelm Medicare Coverage

Meanwhile, Biogen has released additional trial results, which show the benefit of treatment in the longer term with continued reduction of amyloid beta plaques, as well a reduced levels of plasma p-tau181.

Related: Biogen Releases Positive Data on Aduhelm, Takes Over Decision Making

The company has submitted to the FDA its protocol for the confirmatory phase 4 trial. Biogen plans to begin enrolling patients May 2022, with completion expected in four years. The ENVISION trial is a requirement based on FDA’s accelerated approval of Aduhelm. The primary endpoint for the trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months. The trial will also include a planned long-term extension to collect treatment data for up to 48 months.