Rinvoq Approved for Active Ankylosing Spondylitis
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
No reduction in ADRD risk seen for treatment with tofacitinib, tocilizumab, TNF inhibitors versus abatacept
APeX -2 trial findings presented at AAAAI 2022 examine the efficacy of berotralstat, in varying doses, as an oral prophylactic for reducing HAE attacks.
The ongoing phase 3 BE MOBILE 1 study compared the efficacy and safety of bimekizumab to placebo in adults with active nr-axSpA.
The approval was based on data from the 2-year phase 3 JUNIPERA study that evaluated secukinumab in pediatric patients aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
The ongoing phase 3 BE MOBILE 2 study compared the efficacy and safety of bimekizumab to placebo in 332 adults with active ankylosing spondylitis.
The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
Shortly after an EUA was issued, Genentech announced that tocilizumab (marketed under the brand name Actemra) was in shortage.
Findings showed that treatment with secukinumab resulted in a 72% reduction in the risk of flare at week 104 compared with placebo.