Gilead的JAK1抑制剂filgotinib用于治疗RA被FDA给拒了

t
tlexander
楼主 (未名空间)

Gilead的JAK1抑制剂用于治疗RA被FDA给拒了,原因是担心对精子产生有副作用。

A JAK inhibitor, filgotinib has selectivity for a subtype JAK1 of the enzyme, which is why Gilead and Galapagos believe it would have a better safety
profile than less selective JAK inhibitors, such as Pfizer’s Xeljanz (
tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (
upadacitinib), which are on the market.
s
spt009

描述不准确,Filgotinib的三期导致有testicular cancer。我估计gilead最后还是会
重新file的,加上一个black box warning。

【 在 tlexander (Bird) 的大作中提到: 】
: Gilead的JAK1抑制剂用于治疗RA被FDA给拒了,原因是担心对精子产生有副作用。
: A JAK inhibitor, filgotinib has selectivity for a subtype JAK1 of the
enzyme
: , which is why Gilead and Galapagos believe it would have a better safety : profile than less selective JAK inhibitors, such as Pfizer’s Xeljanz (
: tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (
: upadacitinib), which are on the market.