EU/3/08/579

About

On 7 November 2008, orphan designation (EU/3/08/579) was granted by the European Commission to Chiesi Farmaceutici S.P.A., Italy, for ex vivo expanded autologous human corneal epithelium containing stem cells for the treatment of corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns.

Ex vivo expanded autologous human corneal epithelium containing stem cells has been authorised in the EU as Holoclar since 17 February 2015.

Key facts

Active substance
Ex-vivo-expanded autologous human corneal epithelium-containing stem cells
Medicine name
Holoclar
Disease / condition
Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns
Date of decision
07/11/2008
Outcome
Positive
Orphan decision number
EU/3/08/579

Review of designation

During its meeting of 7 to 9 January 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/579 for Holoclar (ex vivo expanded autologous human corneal epithelium containing stem cells) as an orphan medicinal product for the treatment of corneal lesions, with associated corneal (limbal) stem-cell deficiency, due to ocular burns. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment exist in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with this condition. The COMP recommended that the orphan designation of the medicine be maintained1.


1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Sponsor's contact details

Chiesi Farmaceutici S.p.A
Via Palermo, 26/A
43100 Parma
Italy
Tel. +39 0521 27 91
Fax +39 0521 77 41 20
E-mail: info@chiesigroup.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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