Autologous corneal epithelial stem cell therapy - Chiesi/Holostem Terapie Avanzate

Drug Profile

Autologous corneal epithelial stem cell therapy - Chiesi/Holostem Terapie Avanzate

Alternative Names: Holoclar; Limbal epithelial stem cell therapy - Chiesi/Holostem Terapie Avanzate; Living tissue equivalent - Chiesi/Holostem Terapie Avanzate

Latest Information Update: 24 Feb 2015

Price : $50

At a glance

  • Originator Chiesi; Holostem Terapie Avanzate
  • Developer Chiesi
  • Class Eye disorder therapies; Stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

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

    Yes - Limbal stem cell deficiency
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered Limbal stem cell deficiency

Most Recent Events

  • 20 Feb 2015 Registered (conditional approval) for Limbal stem cell deficiency in European Union (Ophthalmic) - First global approval
  • 19 Dec 2014 Holoclar® receives Advanced therapy medicinal product designation for Limbal stem cell deficiency in European Union before December 2014
  • 19 Dec 2014 CHMP recommends approval of Holoclar® for Limbal stem cell deficiency in European Union
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