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Orkambi®, temporary authorization for Use
- Question
- Hello,
A cohort Temporary Authorisation for Use was granted for ORKAMBI® (beginning of ATU: December 2015, Europe)
(http://ansm.sante.fr/Activites/Autorisations-temporaires-d-utilisation-ATU/ATU-de-cohorte-en-cours/Liste-des-ATU-de-cohorte-en-cours/LUMACAFTOR-IVACAFTOR-VERTEX-200-nbsp-mg-125-nbsp-mg-comprime-pellicule [document in French])
Who will benefit from this program?
What should I do as a patient to get into this program?
- Answer
- Hello,
people who can benefit from this drug are cystic fibrosis individuals aged 12 years and older homozygous for the F508del mutation and having no contraindications for this treatment.
You have to contact your CF Center physician to express your wish to enter this program and make sure that you do not have any contraindications and have tracking information provided by this program.
Before meeting with your doctor, you can have comprehensive information by clicking on the link of the website of the National Security Agency of Medicines (ANSM).
ansm.sante.fr/Activites/Autorisations-temporaires-d-utilisation-ATU/ATU-de-cohorte-en-cours/Liste-des-ATU-de-cohorte-en-cours/LUMACAFTOR-IVACAFTOR-VERTEX-200-nbsp-mg-125-nbsp-mg-comprime-pellicule [document in French].
Hope this answer can help.
Best wishes
Gilles RAULT, MD, Roscoff CF Center
- 27.02.2016
