Emapalumab
Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Human |
Target | IFN-gamma |
Clinical data | |
Synonyms | NI-0501 |
Routes of administration | IV, parenteral |
ATC code |
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Identifiers | |
CAS Number | |
ChemSpider |
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UNII | |
Chemical and physical data | |
Formula | C6430H9898N1718O2038S46 |
Molar mass | 154.4 g/mol |
Emapalumab (NI-0501)[1] is an experimental drug in development by Novimmune. It is an anti-IFNγ antibody for the treatment of hemophagocytic lymphohistiocytosis,[2] which currently has no cure.[3]
A phase II/III trial began in 2013 and is ongoing.[4] The trial targets patients under the age of 18 who have failed to improve on conventional treatments.[5]. This study was realised in the context of an EU-funded FP7 project, named FIGHT-HLH (306124)
The FDA awarded orphan drug status in 2012, and breakthrough therapy designation in 2016 on the basis of preliminary data from the phase II trial.[6][7]
References
- ↑ https://searchusan.ama-assn.org/usan/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Femapalumab.pdf
- ↑ https://www.novimmune.com/en/pipeline/ni-0501-anti-ifngamma.html
- ↑ "Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody - Full Text View - ClinicalTrials.gov". clinicaltrials.gov.
- ↑ "A Study to Investigate the Safety and Efficacy of an Anti-IFNγ mAb in Children Affected by Primary Haemophagocytic Lymphohistiocytosis - Full Text View - ClinicalTrials.gov". clinicaltrials.gov.
- ↑ "NI-0501: A Study to Investigate the Safety and Efficacy of an Anti-IFN? mAb in Children Affected by Primary Hemophagocytic Lymphohistiocytosis". www.cincinnatichildrens.org.
- ↑ "Novimmune's NI-0501 Granted Breakthrough Therapy Designation by US FDA for Treatment of Patients With Primary Hemophagocytic Lymphohistiocytosis (HLH) - FierceBiotech". www.fiercebiotech.com.
- ↑ "Emapalumab - NovImmune - AdisInsight". adisinsight.springer.com.
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