Apellis Plans to Seek Re-Examination

Apellis Plans to Seek Re-Examination Following Negative CHMP Opinion on Pegcetacoplan for Geographic Atrophy (GA) in the EU

Friday, June 28th, 2024

Apellis Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA).1

Notably, there were some dissenting votes by CHMP members to this opinion. Apellis plans to seek re-examination and expects a final opinion in the fourth quarter of 2024.

Today’s opinion followed an Ad Hoc Expert Group meeting, in which the experts agreed that size of GA lesion is an acceptable primary outcome measure for a trial in GA and that microperimetry is the best available functional measure in GA. Official press release can be found here.

As a global umbrella group representing charities and foundations who foster and support research into retinal dystrophies, Retina International2 and its member organizations in the European Union (EU) and European Economic Area (EEA) have sincere concerns regarding the impact of this decision.

Mr. Franz Badura, Chair of Retina International said “Pegcetacoplan (Syfovre) has been available to people living with Geographic Atrophy in the United States for over a year, while European patients still have no treatment for their condition. Retina International is disappointed that the very high unmet medical need of this marginalized and vulnerable group remains unaddressed in the European Union.”

GA is a chronic progressive debilitating retinal condition that affects over 1 million Europeans3 and is one of the leading causes of blindness and visual impairment among people older than 65 years.4 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.5,6 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 increase3 in the future due to the ageing population the need to prevent vision loss due to this retinal degenerative disease is urgent.

ENDS

References:

  1. https://investors.apellis.com/news-releases/news-release-details/apellis-plans-seek-re-examination-following-negative-chmp
  2. Retina International (retina-international.org)
  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.
  2. 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.

Retina International — AMD Impact: Cost of Illness Study (retina-international.org)

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