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