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-CSLLatest Information Update: 05 Nov 2023
Price :
$50
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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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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)