HORSHAM, PA—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.1,2 Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)…
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…
(Reuters)—Jacobus Pharmaceutical Co Inc on Monday won U.S. approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. The drug, Ruzurgi (amifampridine), was approved for use in patients ages 6–17, the according to the U.S. Food and Drug Administration (FDA). Lambert-Eaton myasthenic syndrome (LEMS), which affects about three people…
(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Romosozumab-aqqg belongs to a new…