Drotrecogin alfa
- Generic Name
- Drotrecogin alfa
- Drug Type
- Biotech
- CAS Number
- 98530-76-8
- Unique Ingredient Identifier
- JGH8MYC891
- Background
Drotrecogin alfa is activated human protein C that is synthesized by recombinant DNA technology. It is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa was withdrawn from the market after a major study indicated that it was not effective in improving outcomes in patients with sepsis.
- Indication
For reduction of mortality in patients with severe sepsis.
Star Therapeutics' VGA039 Receives FDA Fast Track Designation for Von Willebrand Disease
• The FDA has granted Fast Track designation to Star Therapeutics' VGA039 for von Willebrand disease (VWD), potentially expediting its development.
• VGA039, a monoclonal antibody targeting Protein S, aims to restore blood clotting balance and is designed as a convenient subcutaneous therapy.
• Interim clinical data from a Phase 1 study showed substantial reductions in annualized bleed rates in VWD patients with high bleeding rates.
• Star Therapeutics is advancing VGA039, potentially the first subcutaneous treatment for all types of VWD, into multi-dose studies in early 2025.
Vega Therapeutics' VGA039 Receives FDA Orphan Drug Designation for Von Willebrand Disease
• Vega Therapeutics' VGA039, a first-in-class antibody, has been granted Orphan Drug Designation by the FDA for treating von Willebrand disease (VWD).
• VGA039 modulates Protein S to enhance thrombin generation, addressing a core mechanism of clot formation in VWD.
• A Phase 1 clinical study (NCT05776069) is underway in the EU and US to assess VGA039's safety, tolerability, and pharmacokinetics in healthy volunteers and VWD patients.
• VGA039, designed for subcutaneous self-administration, aims to reduce the treatment burden associated with current VWD therapies.
Drug Development Updates
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