Last reviewed 2026-05-14 · How we verify

EPYSQLI (ECULIZUMAB-AAGH)

EPYSQLI (generic name: ECULIZUMAB-AAGH) is a Complement Inhibitor [EPC] drug developed by SAMSUNG BIOEPIS CO LTD. It is currently FDA-approved.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis [ see Warnings and Precautions ( 5.1 ) ]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of EPYSQLI, unless the risks of delaying therapy with EPYSQLI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions ( 5.1 ) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called EPYSQLI REMS [ see Warnings and Precautions ( 5.2 ) ]. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning. Eculizumab products increase the risk of serious and life-threatening infections caused by Neisseria meningitidis. Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of EPYSQLI, unless the risks of delaying EPYSQLI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. ( 5.1 ) Patients receiving eculizumab products are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of meningococcal infections, and evaluate immediately if infection is suspected. ( 5.1 ) EPYSQLI is available only through a restricted program called the EPYSQLI REMS. ( 5.2 )

Common side effects

• Headache
• Diarrhea
• Hypertension
• Upper respiratory infection
• Abdominal pain
• Vomiting
• Nasopharyngitis
• Anemia
• Cough
• Peripheral edema
• Nausea
• Urinary tract infections

Serious adverse events

• Meningococcal sepsis
• Meningococcal meningitis
• Viral infection
• Anemia
• Pyrexia
• Headache
• Thrombotic event
• Progression of PNH
• Infections

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• EPYSQLI CI brief — competitive landscape report
• EPYSQLI updates RSS · CI watch RSS
• SAMSUNG BIOEPIS CO LTD portfolio CI

Frequently asked questions about EPYSQLI

Related

• Drug class: All Complement Inhibitor [EPC] drugs
• Manufacturer: SAMSUNG BIOEPIS CO LTD — full pipeline
• Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing