Qalsody

Tofersen · Biogen Inc.
PRESCRIPTION ONLY (USA)

Qalsody ingredients

Active ingredientStrength
Tofersen100 mg/15mL

What Qalsody is used for

The FDA lists the approved uses on the official label (below). In the EU, tofersen is approved as Qalsody for:

Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

EU wording from the European Medicines Agency; US approved uses can differ.

Key facts

Brand
Qalsody
Generic name
Tofersen
Made by
Biogen Inc.
Forms
Injection
Given
Intrathecal
Drug class
Antisense Oligonucleotide
FDA approval
New drug application (NDA) NDA215887
On the US market since
2023

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Qalsody?

Qalsody (Tofersen) is a specialist medicine made by Biogen Inc., approved by the US FDA.

What are the ingredients of Qalsody?

Qalsody contains Tofersen (100 mg/15mL).

Is Qalsody approved in Europe?

The same active substance is approved in the EU as Qalsody.

From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, USA

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.