Neurology
ALS with a SOD1 mutation: the approved drugs compared for prescribers
Qalsody side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for ALS with a SOD1 mutation.
The ALS with a SOD1 mutation prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Qalsodytofersen | |
|---|---|
| Label dated | October 23, 2026 |
| Starting dose | Loading doses, 100mg (15mL) each, at 14-day intervals. Remove about 10mL of CSF with the lumbar puncture needle, then inject as a bolus over 1 to 3 minutes. Do not dilute; no external filter needed. |
| Dispensing gate | No REMS and no lab gate; a documented SOD1 mutation, a site with clinicians experienced in lumbar puncture, prior authorization, and pre- and post-procedure evaluation at each dose |
| Required monitoring | No required labs; monitor for myelitis or radiculitis, papilledema or raised intracranial pressure, and aseptic meningitis, with workup per standard of care; evaluate for lumbar puncture complications before and after each dose |
| Example PA threshold | Cigna IP0567 example: age 18 or older, documented SOD1 pathogenic variant, weakness attributable to ALS, adequate respiratory function without invasive ventilation, neurologist, neuromuscular specialist or ALS physician; 6-month approvals |
| Support line | Biogen Support Services, 1-877-725-7639, Monday to Friday 8:30 AM to 8 PM Eastern; Support Coordinators, insurance and financial help, a drug Copay Program and a separate Administration Copay Program for non-government insurance |
- Label dated
- October 23, 2026
- Starting dose
- Loading doses, 100mg (15mL) each, at 14-day intervals. Remove about 10mL of CSF with the lumbar puncture needle, then inject as a bolus over 1 to 3 minutes. Do not dilute; no external filter needed.
- Dispensing gate
- No REMS and no lab gate; a documented SOD1 mutation, a site with clinicians experienced in lumbar puncture, prior authorization, and pre- and post-procedure evaluation at each dose
- Required monitoring
- No required labs; monitor for myelitis or radiculitis, papilledema or raised intracranial pressure, and aseptic meningitis, with workup per standard of care; evaluate for lumbar puncture complications before and after each dose
- Example PA threshold
- Cigna IP0567 example: age 18 or older, documented SOD1 pathogenic variant, weakness attributable to ALS, adequate respiratory function without invasive ventilation, neurologist, neuromuscular specialist or ALS physician; 6-month approvals
- Support line
- Biogen Support Services, 1-877-725-7639, Monday to Friday 8:30 AM to 8 PM Eastern; Support Coordinators, insurance and financial help, a drug Copay Program and a separate Administration Copay Program for non-government insurance
FDA decisions for ALS with a SOD1 mutation
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- October 2026Qalsody. As of November 9, 2026, Drugs@FDA lists only the April 2023 approval for Qalsody, with no letter for the November 2025 revision. Drugs@FDA
- October 2026Qalsody. DailyMed posted a new version of the label on October 26th. Its text reads Revised 11/2025, and its recent major changes list names the myelitis warning with the date left as a placeholder. FDA label
- November 2025Qalsody. The myelitis and radiculitis warning now counts 8 patients instead of 6, with 6 recovering without stopping Qalsody. The label added the final results of the long-term extension study, with longer exposure and updated antibody figures, while the dose stayed the same. FDA label
- November 2024Qalsody. Version 3 of the label took effect on November 13th. Its text matched the April 2023 label in the sections compared for this page, including 6 patients with myelitis or radiculitis. openFDA label record
- April 2023Qalsody. Accelerated approval on April 25th for adults with ALS and a SOD1 mutation, based on lower neurofilament light chain. The FDA required the ATLAS trial to confirm the benefit and asked Biogen to report on myelitis and radiculitis twice a year. FDA letter
Open trials
Questions prescribers ask about ALS with a SOD1 mutation
Does Qalsody require a REMS?
No. Qalsody has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Qalsody require?
No required labs; monitor for myelitis or radiculitis, papilledema or raised intracranial pressure, and aseptic meningitis, with workup per standard of care; evaluate for lumbar puncture complications before and after each dose.
What do insurers require before covering Qalsody?
This is one public insurer policy, an example rather than every plan. Cigna IP0567 example: age 18 or older, documented SOD1 pathogenic variant, weakness attributable to ALS, adequate respiratory function without invasive ventilation, neurologist, neuromuscular specialist or ALS physician; 6-month approvals.
Which support program starts Qalsody patients on therapy?
Biogen Support Services, 1-877-725-7639, Monday to Friday 8:30 AM to 8 PM Eastern; Support Coordinators, insurance and financial help, a drug Copay Program and a separate Administration Copay Program for non-government insurance.
A reference for licensed professionals, checked on November 9, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the ALS with a SOD1 mutation page and the first 90 days pages for Qalsody.