Lybalvi Approved to Treat Schizophrenia and Bipolar I Disorder
June 1, 2021FDA Approves First Novel Antifungal Treatment for Yeast Infections in Over 20 Years
June 2, 2021Cosentyx Receives Expanded Plaque Psoriasis Indication
June 1, 2021 – The U.S. FDA has approved an expanded plaque psoriasis indication for Cosentyx® (secukinumab), manufactured by Novartis. The drug is now indicated to treat moderate to severe plaque psoriasis in patients who are at least six years old and candidates for systemic therapy or phototherapy. Previously, this indication was only FDA approved for adults.
Plaque psoriasis is a chronic inflammatory disease that affects an estimated 8 million people in the United States. It often manifests during childhood, frequently during adolescence. The condition causes raised, red, scaly patches of skin that can be itchy and painful. These patches occur when the body’s immune system attacks healthy skin cells and triggers rapid production of new skin cells.
In a clinical study, Cosentyx reduced plaque psoriasis severity at Week 12 compared to placebo in pediatric patients. Recommended dosing under the expanded indication is 75mg in children who weigh less than 50kg (110 pounds) and 150mg for children weighing 50kg or more, administered via subcutaneous injection once weekly for the first five weeks, then once every four weeks thereafter. It can be self- administered or administered by a caregiver following proper instruction by a healthcare provider.
Cosentyx first received FDA approval in 2015, and is also indicated to treat psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.