News

FDA Approves Higher Concentration of Hadlima, a Humira Biosimilar

The U.S. Food and Drug Administration (FDA) has approved a new, more highly concentrated formulation of Hadlima (adalimumab-bwwd), a biosimilar to AbbVie’s Humira (adalimumab), for the treatment of ankylosing spondylitis. As a biosimilar, Hadlima has similar properties, safety, and efficacy to an approved biological treatment, in this…

New Citrate-free Taltz Becoming Available for AS Patients in US

A new and citrate-free formulation of Taltz (ixekizumab) is being made available to treat adults with active ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA) patients who have signs of inflammation. Symptoms of nr-axSpA are similar to AS, but without X-ray evidence of inflammation. This formulation of the Eli Lilly therapy was…

Rinvoq Approved in Canada for Difficult-to-treat, Active AS 

Health Canada has approved Rinvoq (upadacitinib) to treat active ankylosing spondylitis (AS) in adults who fail to respond to a biologic disease-modifying anti-rheumatic drug (DMARD) or cannot tolerate these therapies. Rinvoq, developed and marketed by AbbVie, can be used alone or in combination with non-steroidal anti-inflammatory drugs (NSAIDs), a common first…

FDA Gives Thumbs-up for Phase 2 Trial of Izokibep in AS Patients

The U.S. Food and Drug Administration (FDA) has cleared the start of a Phase 2 trial of izokibep in people with ankylosing spondylitis (AS), according to the therapy’s developers Affibody AB and Inmagene Biopharmaceuticals. “Obtaining FDA IND [investigational new drug] clearance is an important milestone for the izokibep…

Pandemic Won’t Stop Rare Disease Day on Feb. 28

Scores of virtual events are afoot around the world to mark Rare Disease Day 2021 on Feb. 28. The activities are focused on heightening awareness about rare diseases and the hundreds of millions of individuals they are thought to affect. Patients, caregivers, and advocates worldwide will sport denim ribbons…