EU/3/16/1649

About

On 28 April 2016, orphan designation (EU/3/16/1649) was granted by the European Commission to Abbvie Ltd, United Kingdom, for humanised recombinant IgG4 anti-human tau antibody (also known as ABBV-8E12) for the treatment of progressive supranuclear palsy.

The sponsorship was transferred to AbbVie Deutschland GmbH & Co. KG, Germany, in May 2018.

Key facts

Active substance
Humanised recombinant IgG4 anti-human tau antibody
Disease / condition
Treatment of progressive supranuclear palsy
Date of decision
28/04/2016
Outcome
Positive
Orphan decision number
EU/3/16/1649

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Tel. +49 621 589 3382
E-mail: eu-orphan-drug@abbvie.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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