Apellis Announces Negative CHMP Opinion for Pegcetacoplan for GA

 

Apellis Announces Negative CHMP Opinion for Pegcetacoplan for GA  

Friday, January 26th, 2024 

Apellis Pharmaceuticals, Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and plans to seek immediate re-examination of its application. 

As a global umbrella group representing charities and foundations who foster and support research into retinal dystrophies, Retina International and its member organizations in the European Union (EU) and European Economic Area (EEA) have sincere concerns regarding this impact of this decision.  

Mr. Franz Badura, Chair of Retina International said “The drug pegcetacoplan, has been approved by the Food and Drug Administration3 in the USA and available to patients there for over a year. In that time patients living with GA in Europe and their families have been anxiously awaiting a decision on what would be the first drug available for GA on the European market. Our member organizations in the EU and EEA are extremely disappointed.” 

Retina International and its members are concerned at the impact of today’s decision on the research and innovation landscape in Europe, particularly in the eye and vision space. Preservation of vision and slowing disease progression is a meaningful outcome for patients. 

GA is a chronic progressive debilitating retinal condition that affects over 1 million Europeans4 and is one of the leading causes of blindness and visual impairment among people older than 65 years.5 GA causes a significant economic burden to the individuals affected, their families, as well as to society. In a recent study conducted by Retina International the burden of GA in two European countries (Bulgaria and Germany) was estimated in the range of 229 million to 3.7 billion Euros per year.6,7 So far, there is no therapy available in the European market for this disease.  

Given the severe economic and humanistic burden of the disease that is expected to increase remarkably n the future due to an increase in the ageing population the need to prevent vision loss due to this retinal degenerative disease is urgent. 

 

References: 

  1. Retina International (retina-international.org) 
  1. Apellis Provides Update on Ongoing Regulatory Review of Pegcetacoplan for GA in the European Union – Apellis Pharmaceuticals, Inc. 
  1. Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of Geographic Atrophy (GA) – Apellis Pharmaceuticals, Inc. 
  1. Wong, W.L., Su, X., Li, X., Cheung, C.M.G., Klein, R., Cheng, C.Y. and Wong, T.Y., 2014. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health, 2(2), pp.e106-e116. 
  1. Glatz, M., Riedl, R., Glatz, W., Schneider, M., Wedrich, A., Bolz, M. and Strauss, R.W., 2022. Blindness and visual impairment in Central Europe. PLoS One, 17(1), 

p.e0261897. 

  1. Paudel, N., Brady, L., Stratieva, P. and Daly, A., 2023. Socioeconomic burden of advanced Age-related Macular Degeneration (AMD) in the United States of America (USA), Germany and Bulgaria. Investigative Ophthalmology & Visual Science, 64(8), pp.1746-1746. 
  1. Retina International — AMD Impact: Cost of Illness Study (retina-international.org) 

 

 

 

 

 

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