Uplizna (inebilizumab)
An approved treatment for Myasthenia Gravis.
The same compound appears under different names depending on the context. Here is how to identify Inebilizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Inebilizumab
- Brand name
- Uplizna
- Development code
- MEDI-551
- Drug class
- Anti-CD19 monoclonal antibody
- Manufacturer
- Amgen (via its 2023 acquisition of Horizon Therapeutics)
- How it's taken
- Given as an intravenous infusion of 300 mg, a second 300 mg infusion 2 weeks later, then one 300 mg infusion every 6 months.
A B-cell depleting antibody approved in December 2025 for adults with generalized myasthenia gravis who test positive for AChR or MuSK antibodies. After 2 starting infusions it is given once every 6 months, the least frequent schedule of any targeted myasthenia gravis drug.
Where Inebilizumab fits
The only anti-CD19 B-cell therapy approved for generalized myasthenia gravis, and the least frequent schedule among targeted MG drugs. Approved for AChR or MuSK antibody-positive adults, the same population as Rystiggo; it is not approved for people who test negative for both antibodies, where Vyvgart is the only targeted option. Also approved for NMOSD and IgG4-related disease under a separate page.
How Inebilizumab works
In myasthenia gravis, B cells and the plasmablasts they turn into make antibodies that attack acetylcholine receptors (AChR) or MuSK at the junction between nerve and muscle. Inebilizumab binds CD19, a protein on B cells at most stages of development, including plasmablasts, and the immune system then clears those cells. With fewer antibody-making cells, fewer harmful antibodies are made. This works further upstream than FcRn blockers, which speed up the breakdown of antibodies already made, and complement inhibitors, which block the damage those antibodies trigger.
Mechanism: Anti-CD19 monoclonal antibody that depletes the B cells and plasmablasts that make the antibodies attacking the nerve-muscle connection
Side effects and safety
In the myasthenia gravis trial, the most common side effects were headache (15% on Uplizna versus 7% on placebo) and infusion-related reactions (10% versus 6%). Because it removes B cells, Uplizna can raise the risk of infections, including serious ones, can lower antibody (immunoglobulin) levels over time, and can reactivate hepatitis B. It must not be used in people with active hepatitis B, active or untreated latent tuberculosis, or a past life-threatening reaction to an Uplizna infusion. Live vaccines are not recommended during treatment, and it can harm an unborn baby, so people who can become pregnant should use birth control during treatment and for 6 months after the last dose.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Inebilizumab
Given as an intravenous infusion of 300 mg, a second 300 mg infusion 2 weeks later, then one 300 mg infusion every 6 months. Each infusion takes about 90 minutes, and patients receive a corticosteroid, an antihistamine and a fever reducer beforehand to lower the risk of infusion reactions, then are watched for at least 1 hour afterward. Before the first dose, the label requires testing for hepatitis B and tuberculosis and a measurement of antibody (immunoglobulin) levels.
Availability and cost
Only available as the brand-name product.
Biologic B-cell depleting antibody given as 2 infusions a year after the starting doses. Because it is infused in a clinic, Medicare usually covers it under Part B rather than Part D.
Help paying for Uplizna
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 for UPLIZNA and infusion costs through the Amgen Commercial Co-Pay Program. Not for government insurance.
For: private insurance · source - Infusion cost help
The co-pay program can help with infusion (administration) costs. Residents of Massachusetts or Rhode Island are not eligible for administration support.
For: private insurance · source - Insurance and case manager help
A dedicated Patient Access Liaison helps with insurance approval, prior authorization and scheduling infusions.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Official UPLIZNA pages do not describe a free drug program, and UPLIZNA was not on the Amgen Safety Net Foundation product list. Ask Amgen By Your Side about options if uninsured.
- From a charity · Myasthenia Gravis Foundation of AmericaMGFA Food Support Program fundOpen
Pays for: Meal delivery for food-insecure MG households.
The foundation says: “Applications for the fall cohort of the MGFA Food Support Program are now open.” - From a charity · NORD RareCareMyasthenia Gravis Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCareMyasthenia Gravis Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · The Assistance FundMyasthenia Gravis fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.” - From a charity · TotalAssist (formerly PAN Foundation)Myasthenia Gravis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $10,000 per year. Requires Medicare, Medicaid or TRICARE.
Clinical trial results
The Phase 3 MINT trial (NCT04524273) randomized 238 adults with generalized myasthenia gravis, 190 AChR-positive and 48 MuSK-positive, to Uplizna or placebo. At week 26, MG-ADL scores (a 0 to 24 rating of daily activities like talking, chewing, swallowing and breathing) improved by 4.2 points on Uplizna versus 2.2 on placebo. Patients on steroids began tapering at week 4 with a goal of 5 mg of prednisone a day by week 24, so the benefit was measured while steroid doses were coming down.
Development history
Inebilizumab was developed by MedImmune (AstraZeneca) as MEDI-551 and advanced by Viela Bio, which won its first FDA approval, for AQP4 antibody-positive neuromyelitis optica spectrum disorder, in 2020. Horizon Therapeutics acquired Viela in 2021 and Amgen acquired Horizon in 2023. The FDA approved it for IgG4-related disease in April 2025 and for generalized myasthenia gravis on December 11, 2025, for adults who are anti-AChR or anti-MuSK antibody positive.
Explore Myasthenia Gravis trials
Other Myasthenia Gravis treatments
Common questions about Inebilizumab
▸What is Inebilizumab (Uplizna)?
A B-cell depleting antibody approved in December 2025 for adults with generalized myasthenia gravis who test positive for AChR or MuSK antibodies. After 2 starting infusions it is given once every 6 months, the least frequent schedule of any targeted myasthenia gravis drug.
▸How does Inebilizumab work?
In myasthenia gravis, B cells and the plasmablasts they turn into make antibodies that attack acetylcholine receptors (AChR) or MuSK at the junction between nerve and muscle. Inebilizumab binds CD19, a protein on B cells at most stages of development, including plasmablasts, and the immune system then clears those cells. With fewer antibody-making cells, fewer harmful antibodies are made. This works further upstream than FcRn blockers, which speed up the breakdown of antibodies already made, and complement inhibitors, which block the damage those antibodies trigger.
▸What are the side effects of Inebilizumab?
In the myasthenia gravis trial, the most common side effects were headache (15% on Uplizna versus 7% on placebo) and infusion-related reactions (10% versus 6%). Because it removes B cells, Uplizna can raise the risk of infections, including serious ones, can lower antibody (immunoglobulin) levels over time, and can reactivate hepatitis B. It must not be used in people with active hepatitis B, active or untreated latent tuberculosis, or a past life-threatening reaction to an Uplizna infusion. Live vaccines are not recommended during treatment, and it can harm an unborn baby, so people who can become pregnant should use birth control during treatment and for 6 months after the last dose.
▸How is Inebilizumab taken?
Given as an intravenous infusion of 300 mg, a second 300 mg infusion 2 weeks later, then one 300 mg infusion every 6 months. Each infusion takes about 90 minutes, and patients receive a corticosteroid, an antihistamine and a fever reducer beforehand to lower the risk of infusion reactions, then are watched for at least 1 hour afterward. Before the first dose, the label requires testing for hepatitis B and tuberculosis and a measurement of antibody (immunoglobulin) levels.
▸Is Inebilizumab FDA approved?
Yes, Inebilizumab (Uplizna) is FDA approved (2025) for the treatment of Myasthenia Gravis.
▸Is Uplizna approved for myasthenia gravis?
Yes. The FDA approved Uplizna (inebilizumab) on December 11, 2025, for adults with generalized myasthenia gravis who are anti-AChR or anti-MuSK antibody positive. It is not approved for people who test negative for both antibodies.
▸How often is Uplizna given for myasthenia gravis?
Two 300 mg IV infusions 2 weeks apart, then one 300 mg infusion every 6 months. Each infusion takes about 90 minutes, with premedication beforehand and at least 1 hour of observation afterward.
▸What did the MINT trial show for Uplizna in myasthenia gravis?
In the 238-person MINT trial, MG-ADL scores improved by 4.2 points on Uplizna and 2.2 points on placebo at week 26, while patients on steroids tapered toward 5 mg of prednisone a day.
▸How is Uplizna different from Vyvgart or Soliris?
Uplizna removes the B cells that make myasthenia gravis antibodies. FcRn blockers like Vyvgart lower antibodies that are already circulating, and complement inhibitors like Soliris block the damage the antibodies cause. Uplizna is given twice a year after 2 starting doses, while the others are given every day to every 8 weeks or in repeated cycles.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Amgen · December 11, 2025. FDA Approves UPLIZNA for Adults With Generalized Myasthenia Gravis. https://www.amgen.com/newsroom/press-releases/2025/12/fda-approves-uplizna-for-adults-with-generalized-myasthenia-gravis
- Amgen · Revised September 2026. UPLIZNA (inebilizumab-cdon) Prescribing Information. https://www.pi.amgen.com/united_states/uplizna/uplizna_fpi_english.pdf