Chlorproguanil hydrochloride and dapso

Table of contents

About

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 and dapsone
Disease / condition
Treatment of acute uncomplicated plasmodium falciparum malaria
Date of first decision
26/07/2002
Outcome
Negative
EU designation number
Chlorproguanil hydrochloride and dapso

Sponsor's contact details

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

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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