Emapalumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IFN-gamma |
| Clinical data | |
| Pronunciation | /ˈɛməpəlˌuməb/ EM-a-PAL-eu-mab[1] |
| Trade names | Gamifant |
| Other names | NI-0501, emapalumab-lzsg |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619024 |
| License data |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6430H9898N1718O2038S46 |
| Molar mass | 145352.66 g·mol−1 |
Emapalumab, sold under the brand name Gamifant, is an anti-interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH),[3][4][5] which has no cure.[6]
The most common side effects include infections, hypertension, infusion-related reactions, and pyrexia.[3]
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
In June 2025, the U.S. Food and Drug Administration (FDA) approved emapalumab-lzsg for the treatment of macrophage activation syndrome (MAS) in patients with Still’s disease.[8]
- ^ "STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL" (PDF). Retrieved 21 November 2018.
- ^ "Gamifant (- emapalumab-lzsg injection". DailyMed. 30 June 2020. Retrieved 7 October 2020.
- ^ a b "FDA approves emapalumab for hemophagocytic lymphohistiocytosis". U.S. Food and Drug Administration (FDA). 20 November 2018. Retrieved 19 March 2021. This article incorporates text from this source, which is in the public domain.
- ^ "FDA Approves Gamifant (emapalumab-lzsg), the First and Only Treatment Indicated for Primary Hemophagocytic Lymphohistiocytosis (HLH)" (Press release). Sobi. 20 November 2018. Retrieved 21 November 2018 – via Business Wire.
- ^ Cheloff AZ, Al-Samkari H (July 2020). "Emapalumab for the treatment of hemophagocytic lymphohistiocytosis". Drugs of Today. 56 (7): 439–446. doi:10.1358/dot.2020.56.7.3145359. PMID 32648854. S2CID 220473902.
- ^ Clinical trial number NCT02069899 for "Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody" at ClinicalTrials.gov
- ^ New Drug Therapy Approvals 2018. U.S. Food and Drug Administration (FDA) (Report). January 2019. Archived from the original (PDF) on 26 August 2019. Retrieved 16 September 2020.
- ^ "FDA approves Sobi's Gamifant to treat severe inflammatory arthritis complication - PMLiVE". pmlive.com. 30 June 2025. Retrieved 30 June 2025.