FDA rejects Gilead's would-be blockbuster filgotinib over toxicity concerns

J

Jaybee00

Senior Member (Voting Rights)
https://www.fiercebiotech.com/biote...blockbuster-filgotinib-over-toxicity-concerns

Testicular toxicity!

Wow—This is the drug KDM was promoting, and planning to do trials with.


See here

https://www.s4me.info/threads/smci-...-profiles-in-me-cfs-subgroups”-lombardi.6114/

Meirleir is going to do an official trial in 6 months with 3 groups (Filgotinib, another JAK1 inhibitor and placebo). Filgotinib will be first available on the market in BENELUX (Belgium, Netherlands, Luxembourg) around May 2020. Price range will be around 10.000euro/year/patient according to the CEO from Galapagos. But of course if trials are succesful hopefully refunds via local governments will be possible. Meirleir says it will bring many patients into remission but I am awaiting trial results first... I stay sceptic but optimistic.
Click to expand...


What happened with this?

Is Filg available in Benelux?
 
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Jaybee00 said:
Testicular toxicity!

Wow—This is the drug KDM was promoting, and planning to do trials with.
Click to expand...

It wouldn't be the first anti-rheumatic to affect sperm counts, and if they return to normal when the drug is withdrawn, it may turn out to be an acceptable side effect – a reversible low sperm count isn't harmful to a man who's already fathered his children, or to one who isn't yet planning any. Also, rheumatoid arthritis affects around three times more women than men, so if it's the only serious concern, it would be irrelevant to the majority of patients. It may yet get approval eventually...
 
I saw this safety overview (comparison with JAK inhibitors {Edit:and Humira} already on the market) posted in another place (so I cannot guarantee it's 100% correct) so rejection was not expected.
As for lower sperm count, this was observed in preclinical trials with very high doses on rats, not so far in human trials.

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