Decision

Early access to medicines scheme (EAMS) scientific opinion: Dupilumab as a treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable

EAMS scientific opinion given to Sanofi for the treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 January 2019
• Last updated: 24 June 2019 — See all updates

This publication was withdrawn on 15 August 2019

This publication was withdrawn on 13 August 2019.

This positive scientific opinion has been withdrawn because it has been granted an EU licence.

Documents

Dupixent - Public Assessment Report (PAR)

PDF, 631 KB, 3 pages

Treatment protocol for healthcare professionals

PDF, 839 KB, 27 pages

Treatment protocol for patients

PDF, 176 KB, 7 pages

Treatment protocol on the pharmacovigilance system

PDF, 118 KB, 4 pages

Dupixent - background information for Medical Directors

PDF, 39.6 KB, 2 pages

Details

This positive scientific opinion was issued to Sanofi for Dupixent in the treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis who have responded inadequately to at least one systemic therapy or where the available systemic therapies are not recommended or are not tolerated.

The scientific opinion includes:

• a public assessment report
• a treatment protocol:
  • for healthcare professionals
  • for patients
  • on the pharmacovigilance system
  • EAMs scientific opinion – background information for Medical Directors

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must register patients on the NHS England web based registration system. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net.

For information about access in Northern Ireland, contact Chief Pharmaceutical Officer and Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.gov.uk.

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care at John.Hannah@gov.scot and Rosemarie.parr@gov.scot

For information about access in Wales, contact the Welsh Government Department of Health and Social Services by emailing Andrew Evans, Chief Pharmaceutical Officer at Andrew.Evans@wales.gov.wales and Lynne Schofield, Head of Pharmacy and Prescribing policy at Lynne.Schofield@gov.wales.

Published 24 January 2019
Last updated 24 June 2019 + show all updates

1. 24 June 2019

   Updated contact details for information and details regarding patient access

2. 28 January 2019

   Updated healthcare professionals info

3. 24 January 2019

   First published.