EU/03/14/1276: Orphan designation for the treatment of mucormycosis

Isavuconazonium sulfate

Overview

On 4 June 2014, orphan designation (EU/03/14/1276) was granted by the European Commission to Basilea Medical Ltd, the United Kingdom, for isavuconazonium sulfate for the treatment of mucormycosis.

Update: isavuconazonium sulfate (Cresemba) has been authorised in the EU since 15 October 2015. Cresemba is indicated in adults for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.

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
Intended use
Treatment of mucormycosis
Orphan designation status
Positive
EU designation number
EU/03/14/1276
Date of designation
04/06/2014
Sponsor

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

Review of designation

During its meeting of 1 to 3 September 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/14/1276 for Cresemba (isavuconazole) as an orphan medicinal product for the treatment of mucormycosis. 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 mucormycosis. 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.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cresemba (isavuconazole) for the treatment of mucormycosis (PDF/79.54 KB)

    Adopted

    First published: 05/11/2015
    Last updated: 05/11/2015
    EMA/582963/2015

  • 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.

    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:

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