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Lonoctocog alfa - CSL

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Drug Profile

Lonoctocog alfa - CSL

Alternative Names: Afstyla; CSL-627; NBP-601; Recombinant-factor-VIII-single-chain-CSL; rFVIII - CSL; rVIII-SC - CSL; rVIII-single chain - CSL; rVIII-SingleChain - CSL; Single-chain-recombinant-factor-VIII-CSL

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator SK Chemicals
  • Developer CSL
  • Class Antihaemorrhagics; Blood coagulation factors; Recombinant proteins
  • Mechanism of Action Blood coagulation factor replacements; Factor X stimulants
  • 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 No

Highest Development Phases

  • Marketed Haemophilia A

Most Recent Events

  • 19 Jan 2021 CSL completes a phase III extension trial in Haemophilia A in USA, Australia, Austria, Canada, Czech Republic, France, Georgia, Germany, Hungary, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, South Africa, Spain, Switzerland, Thailand and Ukraine (NCT02172950) (EudraCT2013-003262-13)
  • 30 Sep 2019 Launched for Haemophilia A in Poland, Finland, Finland, Norway, Netherlands, Germany, Austria, Belgium, Denmark prior September 2019 (IV)
  • 01 Dec 2017 Launched for Haemophilia A in Japan (IV)
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