BLOO7 schreef op 20 augustus 2020 11:25:
[...]
Waarom zou je nu nog gaan procederen tegen de instantie die je later de eventuele goedkeuring
moet geven.
Galapagos heeft geen poot om op te staan:
What do we know?
In the preclinical tox models, damage to testis in rats and dogs was observed at
doses producing blood levels of filgotinib slightly higher than blood levels produced
by filgotinib 200mg bid (200mg qd is used in the clinical trials). At these doses, while
sperm counts in rats and dogs increased after filgotinib was stopped, they stayed
low overall and
did not return to normal. At the highest doses tested in male rats and
dogs, these adverse effects did not go away. These adverse effects were not seen
in the testes of rats and dogs when these animals were given a dose that produces
blood levels of filgotinib similar to blood levels produced by the 200 mg daily dose
in humans. (MANTA patient consent form).