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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: 05 Mar 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 Autoimmune haemolytic anaemia; Membranoproliferative glomerulonephritis
  • Phase II Glomerulonephritis; IgA nephropathy; Lupus nephritis; Membranous glomerulonephritis; Thrombotic microangiopathy
  • Phase I/II Wet age-related macular degeneration
  • Preclinical Haemolytic anaemia
  • Discontinued Amyotrophic lateral sclerosis; Ischaemia

Most Recent Events

  • 27 Feb 2024 Apellis Pharmaceuticals completes enrolment in its phase III VALIANT trial for Membranoproliferative glomerulonephritis (In adolescents, In the elderly, Treatment-experienced, In adults) in Australia, USA, Italy, Switzerland, Germany, Netherlands, Czech Republic, Belgium, Austria, France, Poland, Spain, Argentina, Brazil, Canada, Israel, Japan, South Korea and the UK (SC, Injection, Infusion) (EudraCT2020-003767-25) (NCT05067127)
  • 26 Jan 2024 Swedish Orphan Biovitrum suspends a phase III trial in (Indication) in Belgium, Canada, Finland, Georgia, Italy, Japan, Netherlands, United Kingdom, Bulgaria, France, Russia, Ukraine, USA, Germany, Norway, Austria, Spain, Hungary due to decreased medical need impacting recruitment (NCT05096403)
  • 26 Jan 2024 Apellis plans to seek immediate re-examination of the negative CHMP opinion for pegcetacoplan for age-related macular degeneration
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