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Ivacaftor-lumacaftor combination in F508del homozygous patients
- Question
- Could you give us some details for the double deltaF508 mutation? Is the Ivacaftor - lumacaftor combination study positive and in that case, how long will it take until market authorization for those drug and to treat a large proportion of sick patients. Thank you in advance for your response.
- Answer
- Hello,
The results of the study testing the Ivacaftor-lumacaftor combination in homozygous F508del patients were considered positive. Consequently, Vertex Pharmaceuticals, sponsor of the research, announced in a press release (Oct 29th 2014) that it would launch at the end of 2014 a New Drug Application for a market authorization of these products. See page 2 of the following (in English) :
files.shareholder.com/downloads/VRTX/3429941247x0x771927/254e5f55-4d39-4c85-86a4-dc458dda2836/VRTX_News_2014_7_29_General.pdf
By clicking on the following link, you will find also the information posted on the French CF Association website (Vaincre la Mucoviscidose, June 26th 2014) after the announcement of the results of this study:
www.vaincrelamuco.org/ewb_pages/a/actu_11833.php
Sincerely.
Gilles RAULT, MD
Roscoff CF Center
- 10.09.2014
- 10.09.14
Please find even more information under the following links to former Q/As:
ecorn-cf.eu/index.php?id=65&L=8&tx_expertadvice_pi1[showitem]=3103&tx_expertadvice_pi1[search]=Ivacaftor
ecorn-cf.eu/index.php?id=65&L=8&tx_expertadvice_pi1[showitem]=3080&tx_expertadvice_pi1[search]=Ivacaftor
D. d'Alquen
