Xeljanz/Xeljanz XR Approved for 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.
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.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
No difference seen in change in median tibial cartilage volume at 12 months for platelet-rich plasma versus saline placebo injections
The phase 3 COSMOS study evaluated the efficacy and safety of guselkumab in 285 adults with active PsA who had an inadequate response to anti-tumor necrosis factors.
Except for rituximab, no increased risk seen for in-hospital death or mechanical ventilation for those on long-term immunosuppressive therapy
Findings showed that treatment with secukinumab resulted in a 72% reduction in the risk of flare at week 104 compared with placebo.
At five years, no difference seen in symptoms, but rates of subsequent surgical treatment lower with methylprednisolone versus saline injection
This week: The FDA authorize boosters for Moderna and Janssen and okay ‘mixing and matching’ of vaccines for the booster dose. The first interchangeable biosimilar to Humira is approved. Also there’s approvals in dry eye disease, pain management and opioid overdoses.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
No new safety risks were identified in the studies.