A revised label for Janssen Biotech's Simponi Aria, or golimumab, was approved by the FDA. It states that the rheumatoid arthritis treatment in combination with methotrexate improved the emotional and physical well-being of patients, as measured by patient-reported results in the Medical Outcomes Study Short Form-36 questionnaire.
Par Pharmaceutical obtained federal approval for its fenofibric acid delayed-release capsules in two strengths to curb triglycerides and boost levels of high-density lipoprotein cholesterol. The drug is a generic copy of AbbVie's Trilipix.
Janssen Biotech obtained the FDA's approval to market an intravenous formulation of Simponi Aria, or golimumab, in combination with methotrexate as a therapy for moderately to severely active rheumatoid arthritis. The drug, a tumor necrosis factor inhibitor, already was cleared for subcutaneous administration. The approval was based on data from a 592-patient, late-stage trial.
Genentech received approval from the FDA to market Actemra, or tocilizumab, for children 2 and older with active polyarticular juvenile idiopathic arthritis. The drug, a humanized interleukin-6 receptor antagonist, can be given alone or with methotrexate. The approval was based on data from a late-stage trial showing that the drug improved symptoms in children with the condition.