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Replagal (agalsidase alfa for infusion) is indicated for long-term ERT (enzyme replacement therapy) in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).1 Replagal is currently the only human cell line-derived form of the human protein α-galactosidase A that is commercially available.1,2

Replagal ERT was authorised as an orphan medicine by the European Medicines Agency in 2001.1

Replagal is available in the following countries:

AlgeriaFinlandLithuaniaSaudi Arabia
ArgentinaFranceLuxembourgSlovakia
AustriaGermanyMaltaSouth Africa
AustraliaGreeceMexicoSouth Korea
BelgiumHungaryNetherlandsSlovenia
BrazilIcelandNew ZealandSpain
BulgariaIrelandNorwaySweden
CanadaIsraelOmanSwitzerland
ChileItalyParaguayTaiwan
ColombiaJapanPeruTurkey
CroatiaKuwaitPolandUkraine
CyprusLatviaPortugalUnited Kingdom
Czech RepublicLibyaRomaniaUruguay
DenmarkLiechtensteinRussiaVenezuela
Estonia

Reasons for using Replagal® 0.2 mg/kg EOW as ERT in Fabry disease

  1. Effective in the treatment of Fabry disease,3-5 not restricted to particular mutations1
  2. Long-term (10-year) benefits on cardiac and renal function,4 and reduction in the risk of cardiac, cerebrovascular or renal events*5
  3. Demonstrated survival outcomes 5 and improved quality of life3,6-8
  4. The only human cell-derived replacement for the missing α-galactosidase A enzyme1,9
  5. Low potential for immunogenicity*1
  6. Delivered by a well-tolerated,* 40-minute infusion EOW1,10
  7. Risk of disease progression may occur if effective treatment is stopped or interrupted11,12
  8. 15 years of experience1,13
EOW, every other week; ERT, enzyme replacement therapy.
‡Estimated survival
*Please refer to safety information.

References:
1. Replagal (agalsidase alfa), EMA Summary of Product Characteristics, August 2016. Available here.
2. Garman SC & Garboczi DN. J Mol Biol. 2004;337:319-35.
3. Schiffmann R, et al. JAMA. 2001;285:2743-2749.
4. Kampmann C, et al. Orphanet J Rare Dis. 2015;10:125.
5. Beck M, et al. Mol Genet Metab Rep. 2015;3:21-27.
6. Mehta A, et al. Lancet. 2009;374:1986-1996.
7. Baehner F, et al. J Inherit Metab Dis. 2003;26:617-627.
8. Beck M, et al. Eur J Clin Invest. 2004;34:838-844.
9. Bekri S. Importance of glycosylation in enzyme replacement therapy. In: Mehta A, et al. editors. Fabry disease: perspectives from 5 years of FOS. Oxford: Oxford PharmaGenesis Ltd.2006.Chapter 5.
10. Schiffmann R, et al. Nephrol Dial Transplant. 2006;21:345-354.
11. Mehta A, et al. Genet Med. 2010;12:713-720.
12. CHMP. Assessment report on the shortage of Fabrazyme, 2010. Available at www.ema.europa.eu [Accessed 09 November 2016].
13. Giugliani R, et al. JIEMS. 2016;4:1-12.