Pegcetacoplan - Apellis Pharmaceuticals/Swedish Orphan Biovitrum
Alternative Names: APL-2; Aspaveli; EMPAVELI; Pegcetacoplan injection - Apellis Pharmaceuticals/Swedish Orphan Biovitrum; SYFOVRELatest Information Update: 13 Aug 2024
At a glance
- Originator Apellis Pharmaceuticals
- Developer Apellis Pharmaceuticals; Swedish Orphan Biovitrum
- Class Anti-inflammatories; Anti-ischaemics; Antianaemics; Antithrombotics; Cyclic peptides; Eye disorder therapies; Polyethylene glycols; Urologics
- Mechanism of Action Complement C3 inhibitors
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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 Yes
Highest Development Phases
- Marketed Age-related macular degeneration; Paroxysmal nocturnal haemoglobinuria
- Phase III Membranoproliferative glomerulonephritis
- Phase II Glomerulonephritis; IgA nephropathy; Lupus nephritis; Membranous glomerulonephritis; Thrombotic microangiopathy
- Phase I/II Wet age-related macular degeneration
- Discontinued Amyotrophic lateral sclerosis; Autoimmune haemolytic anaemia; Ischaemia
Most Recent Events
- 08 Aug 2024 Apellis Pharmaceuticals announces intention to submit sNDA to US FDA for Membranoproliferative glomerulonephritis (SC, Injection) in early 2025
- 08 Aug 2024 Swedish Orphan Biovitrum announces intention to submit MAA to EMA for Membranoproliferative glomerulonephritis (SC, Injection) in 2025
- 08 Aug 2024 Efficacy and adverse events data from the phase III VALIANT trial in Membranoproliferative glomerulonephritis released by Apellis Pharmaceuticals