Refusal of orphan designation for the treatment of acute uncomplicated plasmodium falciparum malaria

chlorproguanil hydrochloride / dapsone

Table of contents

Overview

On 22 May 2002 the Committee for Orphan Medicinal Products (COMP) adopted a negative opinion on orphan designation of the combination of chlorproguanil hydrochloride and dapsone (Lapdap) in treatment of acute uncomplicated Plasmodium falciparum malaria. A negative decision was granted by the European Commission on 26 July 2002.

The sponsor applied for orphan designation on the basis of assumption of potential significant benefit despite currently available methods of treatment, as well as on the severity and the rarity of the condition.

The negative opinion is based on the following element:

  • Satisfactory methods of treatment of the condition were authorised in the Community, and justification has not been provided that the combination of chlorproguanil hydrochloride and dapsone may be of significant benefit to those affected by the condition in comparison to currently available therapies.

    Lapdap is primarily proposed for treatment of patients in malaria endemic regions of Africa, and does not meet the criteria for orphan designation in Europe.

Requests for designation as orphan medicinal products are made for investigational products. Absence of orphan designation does not preclude the development of this product, in particular through clinical trials, and subsequently the possibility of obtaining a marketing authorisation if quality, safety and efficacy are demonstrated.

Key facts

Active substance
  • chlorproguanil hydrochloride
  • dapsone
Intended use
Treatment of acute uncomplicated plasmodium falciparum malaria
Orphan designation status
Negative
EU designation number
-
Date of refusal of designation
26/07/2002
Sponsor
SmithKline Beecham plc
SB House, Great West Road
Brentford, Middlesex, TW8 9BD
United Kingdom
Telephone: +44 20 8047 5000
Telefax: +44 20 8047 6924
E-mail: josephine.j.wood@gsk.com

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:

How useful was this page?

Add your rating