de tuinman schreef op 3 augustus 2021 22:17:
www.fiercepharma.com/marketing/errati...Another hot topic for specialists is the JAK inhibitor class. Beginning with the FDA's rejection of Gilead’s filgotinib in rheumatoid arthritis last August, JAK inhibitors have been having a tough go. AbbVie’s Rinvoq, Eli Lilly and Incyte’s Olumiant, and Pfizer’s abrocitinib are all sitting in a holding pattern as the FDA scrutinizes Xeljanz’s post-market safety study and holds up new approvals across the whole JAK class.
Rheumatologists and dermatologists agree that it’s OK to scrutinize the class. But the specialists question why the FDA is holding up three JAK meds in atopic dermatitis, plus applications for Rinvoq and Xeljanz in rheumatology, based on a high-risk patient trial for one drug—Xeljanz, Spherix's Lynn Price, VP of strategy and innovation, said.
More than two-thirds of rheumatologists and dermatologists believe the FDA should focus on each individual JAK and its own studies, she said.