EU/3/16/1778: Orphan designation for the treatment of primary IgA nephropathy

budesonide

Overview

On 18 November 2016, orphan designation (EU/3/16/1778) was granted by the European Commission to Pharmalink AB, Sweden, for budesonide for the treatment of primary IgA nephropathy.

In January 2018, Pharmalink AB changed name to Calliditas Therapeutics AB.

The sponsor’s address was updated in July 2021.

The medicinal product (for orphan indication in case of several orphan indications or type II variation) has been authorised in the EU as Kinpeygo since 15 July 2022.

Key facts

Active substance
budesonide
Intended use
Treatment of primary IgA nephropathy
Orphan designation status
Positive
EU designation number
EU/3/16/1778
Date of designation
18/11/2016
Sponsor

STADA Arzneimittel AG
Stadastrasse 2-18
Dortelweil
61118 Bad Vilbel
Hassia
Germany
E-mail: info@stada.de

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Kinpeygo at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the orphan medicine assessment report.

Update history

Date Update
September 2022 The sponsorship was transferred from Calliditas Therapeutics AB, Sweden to STADA Arzneimittel AG, Germany in September 2022.

Documents related to this orphan designation evaluation

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:

Related content

How useful was this page?

Add your rating
Average
1 rating