de tuinman schreef op 24 april 2018 13:13:
www.fiercebiotech.com/biotech/adcomm-...The FDA put out a briefing document last week saying it was "conflicted" on Eli Lilly and Incyte's refiled rheumatoid arthritis drug, baricitinib. And the experts on Monday's advisory committee for the drug's application were no different. The expert panel voted 10-5 in favor of the 2-mg dose but flipped those numbers to vote 10-5 against the 4-mg dose.
But even the affirmative votes seemed shaky at best; memorably, one of the panelists said, “I voted yes, I could have definitely voted no."
The sticking point, predictably, was safety. While the panel voted overwhelmingly in favor of the drug's efficacy—14-1 on 2 mg and 15-0 on 4 mg—they split on safety, voting against the 4-mg dose and in favor of the 2-mg dose. But even this wasn't a decisive victory; the votes fell 9-6 thanks to safety concerns, such as pulmonary embolism and deep vein thrombosis, that the FDA took care to lay out.