Author Archives: Marisa Wexler MS

AbbVie Seeks FDA, EMA Approvals of Rinvoq for Active AS

AbbVie has submitted an application to the U.S. Food and Drug Administration (FDA) requesting the approval of Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis (AS). A separate application was submitted to the European Medicines Agency (EMA) by AbbVie earlier this year,…

FDA Approves Taltz for Non-radiographic Axial Spondyloarthritis

Eli Lilly‘s Taltz (ixekizumab) has been approved in the U.S. to treat non-radiographic axial spondyloarthritis (nr-axSpA) in people who have objective signs of inflammation. “This approval reflects Lilly’s continued growth and commitment to supporting rheumatologists and people with autoimmune conditions, including nr-axSpA,” Patrik Jonsson, senior vice president…

Humira, Smoking Can Alter Gut Microbiome in AS, Study Finds

Both treatment with Humira (adalimumab) and smoking can alter the composition of the gut microbiome — the microorganisms living in the gut — in people with ankylosing spondylitis (AS), a new study shows. Results also revealed that nonsmokers showed greater reductions in disease activity than smokers upon starting Humira. The…

CHMP Recommends Enbrel Biosimilar Nepexto for Approval in Europe

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Nepexto, a biosimilar of Enbrel (etanercept), for the treatment of various inflammatory disorders including ankylosing spondylitis. CHMP is an arm of the European Medicines Agency. and the European Commission generally accepts opinions released…