FDA approved Ultomiris (ravulizumab-cwvz) for Generalized Myasthenia GravisFDA approved Ultomiris for adults with a form of myasthenia gravis.

FDA From the archive Source published December 21, 2018 Summary added June 3, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Ultomiris for adult patients with anti-AChR antibody-positive generalized myasthenia gravis.

The FDA has approved Ultomiris (ravulizumab-cwvz) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Ultomiris is a complement inhibitor that works by blocking complement-mediated damage at the neuromuscular junction. This approval provides a new treatment option for patients with AChR antibody-positive gMG, a chronic autoimmune disease characterized by fluctuating muscle weakness. The approval was based on clinical trial data demonstrating efficacy and safety, though specific trial outcomes are not detailed in the prescribing information. Clinicians should note that Ultomiris is administered as an intravenous infusion with weight-based dosing every 8 weeks after a loading dose.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Ultomiris (ravulizumab-cwvz) is a complement inhibitor. It binds to complement protein C5, inhibiting its cleavage to C5a and C5b, thereby preventing terminal complement-mediated cell damage.

Indication & Patient Population

Ultomiris is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. It is also indicated for other conditions including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adult and pediatric patients one month of age and older, and neuromyelitis optica spectrum disorder (NMOSD) in anti-aquaporin-4 (AQP4) antibody-positive adults.

Dosing & Administration

Ultomiris is administered as an intravenous infusion. For gMG, the recommended dosing is weight-based: for patients 40 kg to less than 60 kg, a loading dose of 2400 mg followed by 3000 mg every 8 weeks; for 60 kg to less than 100 kg, 2700 mg loading then 3300 mg every 8 weeks; for 100 kg or greater, 3000 mg loading then 3600 mg every 8 weeks. The first maintenance dose is given 2 weeks after the loading dose. Dosing may vary within 7 days of scheduled infusion. Supplemental doses are required after plasma exchange, plasmapheresis, or intravenous immunoglobulin. Vaccination against meningococcal infection is required at least 2 weeks prior to initiation, and prescribers must enroll in the ULTOMIRIS and SOLIRIS REMS.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Ultomiris is contraindicated in patients with unresolved serious meningococcal infection. Vaccination against meningococcal serogroups A, C, W, Y and B is required at least 2 weeks before starting treatment. If urgent therapy is needed, antibacterial prophylaxis should be given and vaccines administered as soon as possible. Ultomiris is not indicated for Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).

Place in Therapy

Ultomiris provides a treatment option for adult patients with anti-AChR antibody-positive gMG. As a complement inhibitor, it offers a mechanism distinct from other therapies. Its place in therapy relative to other treatments is not specified in the label.

The FDA has approved a new drug called Ultomiris (ravulizumab-cwvz) for adults with generalized myasthenia gravis (gMG) who test positive for a specific antibody called anti-acetylcholine receptor (AChR). This is a chronic autoimmune disease that causes muscle weakness that can come and go. Ultomiris works by blocking part of the immune system called complement, which can damage the connection between nerves and muscles.

This approval is for patients whose gMG is caused by AChR antibodies. It is given as an intravenous (IV) infusion. The dose is based on body weight and is given every 8 weeks after a first larger dose. The approval was based on clinical trials that showed the drug is effective and safe for this group of patients.

This new option may help people with AChR antibody-positive gMG manage their symptoms. However, it is not a cure. Patients should talk to their doctor to see if Ultomiris is right for them. As with any new treatment, it is important to discuss potential benefits and risks with a healthcare provider.

What this means for you:

Ultomiris is a new IV treatment for certain adults with generalized myasthenia gravis. Talk to your doctor.

Study Details

Study typeFda approval

PublishedDec 2018

View Original Abstract ↓

1 INDICATIONS AND USAGE ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). ( 1.2 ) Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. ( 1.3 ) the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive. ( 1.4 ) 1.1 Paroxysmal Nocturnal Hemoglobinuria ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). 1.2 Atypical Hemolytic Uremic Syndrome ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). 1.3 Generalized Myasthenia Gravis ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. 1.4 Neuromyelitis Optica Spectrum Disorder ULTOMIRIS is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive.

FDA approved Ultomiris (ravulizumab-cwvz) for Generalized Myasthenia GravisFDA approved Ultomiris for adults with a form of myasthenia gravis.

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

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FDA approved Ultomiris (ravulizumab-cwvz) for Generalized Myasthenia GravisFDA approved Ultomiris for adults with a form of myasthenia gravis.

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

Your Blood May Signal a Deadly Clotting Crisis Before It Strikes

Clinical research that matters. Delivered to your inbox.

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