Juvenile Idiopathic Arthritis

Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.

August 11, 2019/by Andrew Humphreys

High Dose of Pfizer’s Xeljanz Raises Red Flag in a Post-Marketing Study

Ankylosing Spondylitis (AS), Blockbusters, Drug Safety Concerns, FDA, FDA/Regulatory, Janus Kinase (JAK) Inhibitors, Juvenile Idiopathic Arthritis, Postmarket Studies, Priority Review, Psoriatic Arthritis, Rheumatoid Arthritis, Therapeutics, Tumor Necrosis Factor (TNF) Inhibitors

Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz has been a strong performer for the company, bringing in $1.77 billion in revenue last year, but now the company has indicated it intends to make a change in a post-marketing study due to safety concerns.

February 21, 2019/by BioSpace

FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Approvals, FDA/Regulatory, Interleukin-6 (IL-6), New Formulations, Systemic Juvenile Idiopathic Arthritis (SJIA)

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

September 13, 2018/by Business Wire

FDA approves Cyltezo, a biosimilar to Humira

Ankylosing Spondylitits, Approvals, Biosimilars, Blockbusters, Crohn's Disease, FDA, FDA/Regulatory, Inflammatory Diseases, Juvenile Idiopathic Arthritis, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis

The FDA approved Boehringer Ingelheim Pharmaceuticals’ Cyltezo, a biosimilar to Humira, in a pre-filled syringe for treating chronic inflammatory diseases.

August 29, 2017/by PR Newswire