EU/3/14/1284

About

On 4 July 2014 orphan designation (EU/3/14/1284) was granted by the European Commission to Basilea Medical Ltd, United Kingdom, for isavuconazonium sulfate for the treatment of invasive aspergillosis.

Update: isavuconazonium sulfate (Cresemba) has been authorised in the EU since 15 October 2015. Cresemba is indicated in adults for the treatment of invasive aspergillosis.

Consideration should be given to official guidance on the appropriate use of antifungal agents.

The sponsorship was transferred to Basilea Pharmaceutica Deutschland GmbH, Germany, in April 2019.

Key facts

Active substance
Isavuconazonium sulfate
Medicine name
Cresemba
Disease / condition
Treatment of invasive aspergillosis
Date of first decision
04/07/2014
Outcome
Positive
EU designation number
EU/3/14/1284

Review of designation

During its meeting of 1 to 3 September 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/14/1284 for Cresemba (isavuconazole) as an orphan medicinal product for the treatment of invasive aspergillosis. 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 are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with invasive aspergillosis. The COMP recommended that the orphan designation of the medicine be maintained*.

*The 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

Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8
79539 Loerrach
Germany
Tel. +49 7621 1639475
E-mail: medical.lnformation@basilea.com

Patients' organisations

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;

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