EU/3/17/1929

About

On 16 October 2017, orphan designation (EU/3/17/1929) was granted by the European Commission to Envestia Limited, United Kingdom, for recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8 (also known as AK002) for the treatment of mastocytosis.

The sponsorship was transferred to Turnkey Pharmaconsulting Ireland Limited, Ireland, in October 2019.

Key facts

Active substance
Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8
Disease / condition
Treatment of mastocytosis
Date of first decision
16/10/2017
Outcome
Positive
EU designation number
EU/3/17/1929

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

Turnkey Pharmaconsulting Ireland Limited
Ellerman House 
Cratloe Wood 
Cratloe 
Co. Clare 
Ireland 
Tel: +353 86 844 6816 
E-mail: markturner@turnkeypharmaconsulting.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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