Biogen pulls their European application for Aduhelm
Biogen pulls their European application for Aduhelm
In another setback for Biogen’s controversial Aduhelm, the company pulled their European application for the drug
On Friday, April 22nd, 2022, Biogen announced that it had withdrawn the marketing application in the EU for aducanumab (Aduhelm), its monoclonal antibody that targets aggregated forms of amyloid beta found in the brains of Alzheimer’s patients. This occurred following a meeting with the European Medicines Agency (EMA) that dashed hopes for a successful re-examination of the negative Committee for Medicinal Products for Human Use (CHMP) opinion adopted last November. The EMA had indicated that the data package provided, especially with regards to safety, would not be sufficient to support a marketing authorization. This comes in addition to the news in the US, where Centers for Medicare & Medicaid Services (CMS) implemented a restrictive reimbursement policy for Aduhelm, where it is only reimbursed for Medicare patients in clinical trials. Given this, Biogen’s hopes for Aduhelm have dimmed, and as many as 1,000 jobs are on the line given the current situation, possibly the largest reduction in Biogen’s workforce ever.
Key Considerations:
After significant controversy in the US, this latest regulatory setback in Europe once again prompts questions on the FDA’s initial approval, and perhaps adds support to a restrictive reimbursement decision. As Aduhelm’s hopes have been dashed in the EU and significantly diminished in the US, Roche’s gantenerumab and Eli Lilly’s donanemab (which are both indicated to target amyloid beta build up in Alzheimer’s disease patients) may face challenging barriers for regulatory approval and reimbursement. Nonetheless, not all doors are closed for drug development in the Alzheimer’s space. In CMS’s final decision, the agency noted that they are open to providing broader coverage, (including for outpatient and infusion center settings) for anti-beta amyloid drugs with full FDA approval based on cognitive benefits from clinical trials. Ultimately, the future of the Alzheimer’s disease space will depend upon anticipated Phase 3 trial results for Roche’s gantenerumab in 2022 and for Lilly’s donanemab in 2023.
Article co-authored by Crystal Leung, Senior Analyst and Colin Banks, Analyst at Windrose Consulting Group