Managed Healthcare Executive October 23, 2024
This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.
Alvotech and Teva Pharmaceuticals announced this week the FDA approval of Selardsi (ustekinumab-aekn) to treat adults with moderately severe and severe Crohn’s disease or ulcerative colitis, according to a news release. This approval is an expansion on the reference product Stelara and is expected to launch in the first quarter of 2025 in the United States.
Selardsi will be available in a 130 mg/26mL single dose and will be administered intravenously. Dosage is dependent on weight. If the patient weighs 121 pounds or less, they will be given two vials. Patients weighing between 121 pounds and 187 pounds should take three vials. Patients weighing more...