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VX 770
- Question
- Hello,
A CF individual from France told me that the French health authorities do not give approval for VX 770 (not even via the "named patient program" of Vertex) since it is supposed to cause hepatitis side effects. Do you know more about it?
[The second part of the question was only relevant for Germany and therefore is not published in the Central Archive.]
Many thanks.
- Answer
- Dear questioner,
You are referring to the new drug that is supposed to come on the German market this year [2012]. Before approval, in Germany the drug can be used for treatment of CF patients at the expense of the producer within a special program if the CF patient fulfils certain conditions (genotype G551D and FEV1 smaller than 40%) and if diagnosis is accordingly, i.e. that the need for this therapy has to be tested thoroughly by a physician. While being treated with this drug, the patient has to be monitored thoroughly, this also includes an ongoing check of the liver function since increased liver values form part of the possible side effects. We are not able to give any information about the decision of the French health authorities against the approval of the drug since we do not have knowledge about it.
[The second part of the answer was only relevant for Germany and therefore is not published in the Central Archive.]
Best regards,
Dr. Christina Smaczny
- 22.03.2012
