Author Archives: Marisa Wexler MS

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…

Mabpharm Seeks Approval of Infliximab Biobetter in China

Mabpharm has filed an application with China’s National Medical Products Administration (NMPA) seeking approval of a biobetter of infliximab, a biological treatment for people with ankylosing spondylitis and other inflammatory disorders. Sorrento Therapeutics, the company owning global rights to the biobetter antibody outside of China,…