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Mavrilimumab - Kiniksa Pharmaceuticals

Drug Profile

Mavrilimumab - Kiniksa Pharmaceuticals

Alternative Names: Anti-GM-CSFR monoclonal antibody - MedImmune; CAM-3001; KPL-301

Latest Information Update: 12 Dec 2018

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At a glance

  • Originator Zenyth Therapeutics
  • Developer Kiniksa Pharmaceuticals; MedImmune
  • Class Antirheumatics; Monoclonal antibodies; Vascular disorder therapies
  • Mechanism of Action Granulocyte macrophage colony stimulating factor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Giant cell arteritis
  • Discontinued Rheumatoid arthritis

Most Recent Events

  • 06 Dec 2018 The US FDA places a clinical hold on a submitted IND application for a phase II trial in Giant cell arteritis, as additional information has been requested regarding the delivery device to be used in the trial
  • 06 Aug 2018 Kiniksa Pharmaceuticals announces intention to submit CTA for a phase II trial for Giant cell arthritis in 2H 2018 (Kiniksa Pharmaceuticals pipeline, May 2018)
  • 06 Aug 2018 Kiniksa Pharmaceuticals plans a pre-investigational new drug application meeting with US FDA for Giant cell arteritis
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