Neurology
Neuromyelitis optica spectrum disorder (NMOSD): the approved drugs compared for prescribers
Enspryng, Uplizna 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 neuromyelitis optica spectrum disorder (NMOSD).
The 2 neuromyelitis optica spectrum disorder (NMOSD) prescribing guides
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.
| Enspryngsatralizumab-mwge | Upliznainebilizumab-cdon | |
|---|---|---|
| Label dated | October 23, 2026 | September 21, 2026 |
| Starting dose | 120mg SC, first loading dose, under the guidance of a qualified HCP. | 300mg IV, titrated to completion over about 90 minutes. |
| Dispensing gate | No REMS. HBV, TB and liver transaminase plus bilirubin screening before dose 1, live vaccines at least 4 weeks before, ENSPRYNG Start Form, prior authorization, and HCP-guided first injection | No REMS. HBV, quantitative immunoglobulin and TB screening before dose 1, immunizations at least 4 weeks before, prior authorization, a site of care, and no active infection on each dose day |
| Required monitoring | ALT and AST every 4 weeks for 3 months, then every 3 months for one year. Neutrophils at 4 to 8 weeks, then at clinical intervals; infection check before every dose | Premedicate every infusion; observe during and 1 hour after; infection check before each dose; immunoglobulins at baseline, during treatment and until B-cell repletion; HBV monitoring for at-risk patients |
| Example PA threshold | FEP example: age 18 or older, anti-AQP4 antibody positive, baseline AST, ALT and bilirubin, agreement to monitor AST, ALT and neutrophils, no active HBV, no active or untreated latent TB | FEP example: age 18 or older, anti-AQP4 antibody positive, no active HBV, no active or untreated latent TB, no concurrent live vaccines |
| Support line | ENSPRYNG Access Solutions, 1-844-677-7964 (1-844-NSPRYNG), Mon to Fri 6am to 5pm PT; as little as $0 per 30-day supply on eligible commercial plans, up to $20,000 a year | Amgen By Your Side, Patient Access Liaison 1-833-842-8477; as little as $0 for drug and infusion costs on eligible commercial plans; no administration support for MA or RI residents |
- Label dated
- October 23, 2026
- Starting dose
- 120mg SC, first loading dose, under the guidance of a qualified HCP.
- Dispensing gate
- No REMS. HBV, TB and liver transaminase plus bilirubin screening before dose 1, live vaccines at least 4 weeks before, ENSPRYNG Start Form, prior authorization, and HCP-guided first injection
- Required monitoring
- ALT and AST every 4 weeks for 3 months, then every 3 months for one year. Neutrophils at 4 to 8 weeks, then at clinical intervals; infection check before every dose
- Example PA threshold
- FEP example: age 18 or older, anti-AQP4 antibody positive, baseline AST, ALT and bilirubin, agreement to monitor AST, ALT and neutrophils, no active HBV, no active or untreated latent TB
- Support line
- ENSPRYNG Access Solutions, 1-844-677-7964 (1-844-NSPRYNG), Mon to Fri 6am to 5pm PT; as little as $0 per 30-day supply on eligible commercial plans, up to $20,000 a year
- Label dated
- September 21, 2026
- Starting dose
- 300mg IV, titrated to completion over about 90 minutes.
- Dispensing gate
- No REMS. HBV, quantitative immunoglobulin and TB screening before dose 1, immunizations at least 4 weeks before, prior authorization, a site of care, and no active infection on each dose day
- Required monitoring
- Premedicate every infusion; observe during and 1 hour after; infection check before each dose; immunoglobulins at baseline, during treatment and until B-cell repletion; HBV monitoring for at-risk patients
- Example PA threshold
- FEP example: age 18 or older, anti-AQP4 antibody positive, no active HBV, no active or untreated latent TB, no concurrent live vaccines
- Support line
- Amgen By Your Side, Patient Access Liaison 1-833-842-8477; as little as $0 for drug and infusion costs on eligible commercial plans; no administration support for MA or RI residents
FDA decisions for neuromyelitis optica spectrum disorder (NMOSD)
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 2026Enspryng. The FDA added thyroid eye disease in adults as a second use. The NMOSD dose, tests and warnings did not change. FDA letter
- September 2026Uplizna. The FDA label added instructions for drawing Uplizna from the vial, using a fine needle and no vial spikes or closed transfer devices. The dose, tests and warnings did not change. FDA label
- June 2026Enspryng. The label's administration instructions were revised in June 2026. That version lists a 120mg autoinjector alongside the 120mg prefilled syringe. June 2026 label
- December 2025Uplizna. The FDA added generalized myasthenia gravis as a third use, with the same dose schedule. The warnings on infusion reactions and infections were updated with data from that trial. FDA letter
- April 2025Uplizna. The FDA added IgG4-related disease as a second use. The NMOSD dose did not change. FDA letter
- September 2022Enspryng. The FDA approved adding the phone number for the NMOSD pregnancy registry to the label and the Medication Guide. FDA letter
- May 2021Enspryng. The FDA approved corrections to the body weight data in the side effects section. FDA letter
- August 2020Enspryng. The FDA approved Enspryng for adults with NMOSD who are AQP4 antibody positive. It was the first approval for the drug. FDA letter
Open trials
Questions prescribers ask about Neuromyelitis optica spectrum disorder (NMOSD)
Which Neuromyelitis optica spectrum disorder (NMOSD) drugs require a REMS?
None of the 2 Neuromyelitis optica spectrum disorder (NMOSD) drugs on this page has a REMS: Enspryng and Uplizna. Each prescribing guide lists what does gate the first fill.
What monitoring do Neuromyelitis optica spectrum disorder (NMOSD) drugs require?
Enspryng: ALT and AST every 4 weeks for 3 months, then every 3 months for one year. Neutrophils at 4 to 8 weeks, then at clinical intervals; infection check before every dose. Uplizna: Premedicate every infusion; observe during and 1 hour after; infection check before each dose; immunoglobulins at baseline, during treatment and until B-cell repletion; HBV monitoring for at-risk patients.
What do insurers require before covering Enspryng and Uplizna?
Each answer below is one public insurer policy, an example rather than every plan. Enspryng: FEP example: age 18 or older, anti-AQP4 antibody positive, baseline AST, ALT and bilirubin, agreement to monitor AST, ALT and neutrophils, no active HBV, no active or untreated latent TB. Uplizna: FEP example: age 18 or older, anti-AQP4 antibody positive, no active HBV, no active or untreated latent TB, no concurrent live vaccines.
Which support programs start Neuromyelitis optica spectrum disorder (NMOSD) patients on therapy?
Enspryng: ENSPRYNG Access Solutions, 1-844-677-7964 (1-844-NSPRYNG), Mon to Fri 6am to 5pm PT; as little as $0 per 30-day supply on eligible commercial plans, up to $20,000 a year. Uplizna: Amgen By Your Side, Patient Access Liaison 1-833-842-8477; as little as $0 for drug and infusion costs on eligible commercial plans; no administration support for MA or RI residents.
A reference for licensed professionals, checked on November 8, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Neuromyelitis optica spectrum disorder (NMOSD) page and the first 90 days pages for Enspryng, Uplizna.