OMS 721

Drug Profile

OMS 721

Alternative Names: anti-MASP-2 monoclonal antibody; MASP-2 antibody - Omeros Corporation; MASP-2 therapeutic; OMS 00620646; OMS 620646; OMS-721

Latest Information Update: 26 Jul 2018

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At a glance

  • Originator Omeros Corporation
  • Class Anti-inflammatories; Antithrombotics; Monoclonal antibodies
  • Mechanism of Action MASP2 protein inhibitors
  • Orphan Drug Status

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

    Yes - Thrombotic microangiopathies; IgA nephropathy
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Haemolytic uraemic syndrome; IgA nephropathy; Thrombotic microangiopathies
  • Phase II Glomerulonephritis; Lupus nephritis; Membranous glomerulonephritis
  • No development reported Stroke; Wet age-related macular degeneration

Most Recent Events

  • 25 Jul 2018 EMA's Committee for Orphan Medicinal Products recommends orphan drug designation for OMS 721 in European Union for Thrombotic microangiopathies (haematopoietic stem cell transplantation associated microangiopathy)
  • 10 May 2018 Omeros Corporations announces intention to scheduling meetings with EMA to discuss plans for submission of an application for conditional marketing authorisation for Thrombotic microangiopathies (haematopoietic stem cell transplant-associated thrombotic microangiopathy)
  • 10 May 2018 Omeros Corporations announces intention to submit rolling BLA to US FDA for Thrombotic microangiopathies (haematopoietic stem cell transplant-associated thrombotic microangiopathy) later in 2018
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