# Biogen

Canonical page: https://technooptimist.io/companies/biogen
US neuroscience drugmaker. It licensed tofersen from Ionis and sells it as Qalsody, the first drug that targets a genetic cause of ALS.

## In brief

- Qalsody: FDA accelerated approval April 2023, EU approval May 2024, for ALS caused by SOD1 mutations.
- ATLAS phase 3 tests whether starting tofersen before symptoms can delay or prevent ALS.

## Facts

- Headquarters: US
- Status: public
- Website: https://www.biogen.com
- Frontiers: [Biotech](https://technooptimist.io/biotech.md) (RNAi & antisense drugs)

## Programs

- [Qalsody (tofersen)](https://technooptimist.io/biotech/qalsody.md) (Biotech): Deploy; next: ATLAS: treat presymptomatic SOD1 carriers when neurofilament rises. Approved in the US (2023) and EU (2024); ATLAS trial in presymptomatic SOD1 carriers ongoing.

## Latest updates

- **May 2024**: EU approves Qalsody for SOD1-ALS under exceptional circumstances. The European Commission authorised tofersen for adults with SOD1-ALS, the first EU treatment aimed at a genetic cause of ALS. ([our story](https://technooptimist.io/stories/eu-approves-qalsody-for-sod1-als-under-exceptional-circumstances-cfea268a.md) · [original source](https://www.europeanpharmaceuticalreview.com/news/229724/oligonucleotide-als-therapy-approved-in-eu/))
- **25 Apr 2023**: FDA grants accelerated approval to Qalsody, the first treatment targeting a genetic cause of ALS. The FDA approved tofersen (Qalsody) for adults with ALS caused by SOD1 mutations, based on a drop in neurofilament light, a blood marker of nerve damage. ([our story](https://technooptimist.io/stories/fda-grants-accelerated-approval-to-qalsody-the-first-treatment-8e3330b4.md) · [original source](https://www.sec.gov/Archives/edgar/data/874015/000114036123020335/brhc20051944_ex99-1.htm))

## Partners, customers and investors

- Ionis Pharmaceuticals (partner): Ionis discovered tofersen; Biogen licensed, developed and sells it.

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