On 22 May 2006, orphan designation (EU/3/06/372) was granted by the European Commission to DuoCort AB, Sweden, for hydrocortisone (modified-release tablet) for the treatment of adrenal insufficiency.
The sponsorship was transferred to DuoCort Pharma AB, Sweden, in November 2008 and subsequently to ViroPharma SPRL, Belgium, in February 2012.
In February 2016, ViroPharma SPRL changed name to Shire Services BVBA.
Hydrocortisone (modified release tablet) has been authorised in the EU as Plenadren since 3 November 2011.
Treatment of adrenal insufficiency
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Review of designation
During its meeting of 21 to 23 March 2016, the Committee for Orphan Medicinal Products (COMP) assessed whether Plenadren (hydrocortisone) still met the criteria for orphan designation as there appeared to be an increase in the prevalence of the condition.1 Plenadren has been authorised in the European Union for the treatment of adrenal insufficiency since 3 November 2011. At the time, because Plenadren met the criteria for orphan designation, it was granted 10 years of market exclusivity in the EU.2
A Member State can ask that this period of market exclusivity be reduced to 6 years if at the end of 5 years the criteria for orphan designation no longer apply and the medicine is sufficiently profitable.
At the request of the United Kingdom, the COMP therefore reviewed the criteria for orphan designation for Plenadren. The Committee looked at the seriousness and prevalence of the condition and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with adrenal insufficiency. As these criteria continue to be met, the COMP recommended that the 10-year period of market exclusivity granted to Plenadren in 2011 for the treatment of adrenal insufficiency should not be reduced.
For more information about the original review at the time of initial marketing authorisation see:
- Recommendation for maintenance of orphan designation at the time of marketing authorisation: Plenadren (hydrocortisone) for the treatment of adrenal insufficiency
1In accordance with Article 8(2) of Regulation (EC) No 141/2000.
2This means that in the 10 years after authorisation similar products for the same therapeutic indication cannot be placed on the market.
Documents related to this orphan designation evaluation
COMP assesses whether Plenadren still meets orphan designation criteria: recommendation to maintain the period of market exclusivity at 10 years: Plenadren (hydrocortisone) for the treatment of adrenal insufficiency (PDF/113.5 KB)
First published: 03/05/2016
Last updated: 25/11/2021
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: