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Mim 8

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Drug Profile

Mim 8

Alternative Names: Coagulation factor VIII mimetic antibody - Novo Nordisk; FVIII mimetic antibody - Novo Nordisk; Mim-8; NN 7769; NN0365-3769; NNC0365-3769; NNC0365-3769 A

Latest Information Update: 09 Aug 2024

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At a glance

  • Originator Novo Nordisk
  • Developer Genmab; Novo Nordisk
  • Class Antihaemorrhagics; Bispecific antibodies
  • Mechanism of Action Blood coagulation factor stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Haemophilia A

Most Recent Events

  • 07 Aug 2024 Novo Nordisk completes a phase-III trial in Haemophilia A (In adolescents, In the elderly, In adults) in Japan, USA, United Kingdom, Turkey, Switzerland, Spain, South Africa, Serbia, Saudi Arabia, Russia, Romania, Mexico, Malaysia, India, France, Czech Republic, China, Canada, Slovakia, Ireland, Denmark, Belgium, Germany, Austria, Latvia, Lithuania, Netherlands, Poland, Portugal, Italy, South Korea, Israel and Taiwan (SC) (NCT05053139)
  • 23 Jun 2024 Efficacy and adverse event data from the phase III FRONTIER 2 trial in Haemophilia A released by Novo Nordisk
  • 13 May 2024 Novo Nordisk plans to submit Mim 8 for the first regulatory approval towards the end of 2024

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