# EU approves Qalsody for SOD1-ALS under exceptional circumstances

Canonical page: https://technooptimist.io/stories/eu-approves-qalsody-for-sod1-als-under-exceptional-circumstances-cfea268a
Date: May 2024
About: [Biogen](https://technooptimist.io/companies/biogen.md) · [Qalsody (tofersen)](https://technooptimist.io/biotech/qalsody.md)
Original source: https://www.europeanpharmaceuticalreview.com/news/229724/oligonucleotide-als-therapy-approved-in-eu/

The European Commission authorised tofersen for adults with SOD1-ALS, the first EU treatment aimed at a genetic cause of ALS. The approval was granted under exceptional circumstances, used when full data are hard to collect in a rare disease, and Biogen may need to provide more confirmatory evidence. The European Academy of Neurology now recommends it as first-line treatment for SOD1-ALS.

## Key facts

- Basis: VALOR, with plasma neurofilament down 55% vs up 12% on placebo at week 28.
- Orphan designation; Biogen's third rare-disease approval in the EU.

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