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

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/

What happened with this?

Is Filg available in Benelux?

 

https://www.barrons.com/amp/article...ockbusters-scrambling-drug-stocks-51597846377

 

It wouldn't be the first anti-rheumatic to affect sperm counts, and if they return to normal when the drug is withdrawn, it may turn out to be an acceptable side effect – a reversible low sperm count isn't harmful to a man who's already fathered his children, or to one who isn't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.

 

Looks like it’s still under consideration for the EU.

EMA Panel Backs Filgotinib (Jyseleca) for Rheumatoid Arthritis


https://www.medscape.com/viewarticle/934782

 

Approval today in both Japan and Europe for Jyseleca / Filgotinib.