Emapalumab

Emapalumab
Monoclonal antibody
Type Whole antibody
Source Human
Target IFN-gamma
Clinical data
Synonyms NI-0501
Routes of
administration
IV, parenteral
ATC code
  • none
Identifiers
CAS Number
ChemSpider
  • none
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

  1. https://searchusan.ama-assn.org/usan/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Femapalumab.pdf
  2. https://www.novimmune.com/en/pipeline/ni-0501-anti-ifngamma.html
  3. "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.
  4. "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.
  5. "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.
  6. "Novimmune's NI-0501 Granted Breakthrough Therapy Designation by US FDA for Treatment of Patients With Primary Hemophagocytic Lymphohistiocytosis (HLH) - FierceBiotech". www.fiercebiotech.com.
  7. "Emapalumab - NovImmune - AdisInsight". adisinsight.springer.com.
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