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Pegcetacoplan - Apellis Pharmaceuticals/Swedish Orphan Biovitrum

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Drug Profile

Pegcetacoplan - Apellis Pharmaceuticals/Swedish Orphan Biovitrum

Alternative Names: APL-2; Aspaveli; EMPAVELI; Pegcetacoplan injection - Apellis Pharmaceuticals/Swedish Orphan Biovitrum; SYFOVRE

Latest Information Update: 03 Jul 2024

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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
  • Orphan Drug Status

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

    Yes - Autoimmune haemolytic anaemia; Paroxysmal nocturnal haemoglobinuria; Glomerulonephritis
  • 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

  • 28 Jun 2024 Apellis plans to seek re-examination and expects a final opinion for pegcetacoplan for age-related macular degeneration from the Committee for Medicinal Products for Human Use (CHMP) in the fourth quarter of 2024
  • 28 Jun 2024 Apellis receives negative opinion for pegcetacoplan for age-related macular degeneration from the Committee for Medicinal Products for Human Use (CHMP) in EU
  • 10 Jun 2024 Updated fficacy data from phase III GALE extension trial in Age-related macular degeneration released by Apellis Pharmaceuticals
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