Drug Profile


Alternative Names: ACE 910; Anti-factor IXa x anti-factor X humanized bispecific antibody; CH5534262; RG 6013; RO 5534262

Latest Information Update: 10 Aug 2017

$50 / €47 *
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At a glance

  • Originator Chugai Pharmaceutical
  • Developer Chugai Pharmaceutical; Roche
  • Class Antihaemorrhagics; Bispecific antibodies; Monoclonal antibodies; Recombinant proteins
  • Mechanism of Action Blood coagulation factor replacements
  • Orphan Drug Status

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

    Yes - Haemophilia A
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Haemophilia A

Most Recent Events

  • 21 Jul 2017 Preregistration for Haemophilia A (In adolescents, In children, In adults, In infants) in Japan (SC)
  • 10 Jul 2017 Genentech submits data from HAVEN 1 and HAVEN 2 studies to US FDA and EMA for approval consideration
  • 10 Jul 2017 Pooled adverse events and efficacy data from two phase III trials HAVEN 1 and HAVEN 2 in Haemophilia A released by Genentech
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