The products include Crovalimab, Dapagliflozin, Secukinumab, Roflumilast
The FDA has accepted a biologics license application (BLA) for crovalimab, an investigational anti-C5 recycling monoclonal antibody, to treat paroxysmal nocturnal hemoglobinuria. The role of crovalimab is to block a vital part of the immune system that acts as the first line of defense against infections. The BLA was approved based on results from the phase 3 COMMODORE 2 study (NCT04434092) in individuals with PNH, which found that the treatment managed disease, was well tolerated, and was noninferior to eculizumab (Soliris; Alexion), a current standard of care. Individuals in the study were 18 years and older and had not been previously treated with complement inhibitors. Reported adverse events included infusion-related reactions, occurring in 78% of individuals who were treated with crovalimab and 80% of individuals who were treated with eculizumab.
FOR MORE INFORMATION: gene.com
New findings in the T2NOW phase 3 trial (NCT01042977) found that dapagliflozin demonstrated a significant reduction in hemoglobin A1C for children and adolescents with type 2 diabetes compared with a placebo. Investigators found that the adjusted mean change in A1C was –0.62% for dapagliflozin compared with 0.41% for the placebo. The study’s primary end point was achieved as were all secondary end points, with dapagliflozin providing clinically meaningful improvements in glycemia at week 26 compared with the placebo. The results were presented at the 59th Annual Meeting of the European Association for the Study of Diabetes and published in the New England Journal of Medicine.
FOR MORE INFORMATION: astrazeneca.com
FDA officials have approved an intravenous (IV) formulation of secukinumab for the treatment of adults with psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondylarthritis, making it the first IV formulation that specifically targets and blocks interleukin-17A and the only nontumor necrosis factor a IV option available in these indications. The IV formulation is administered in monthly, 30-minute, weight-based dosing and requires no premedication or lab monitoring. It will be available in the fourth quarter of 2023, according to the company.
FOR MORE INFORMATION: novartis.com
From: Arcutis Biotherapeutics
The FDA has approved a supplemental new drug application to expand the indication of steroidfree roflumilast cream 0.3% to include the treatment of plaque psoriasis and intertriginous areas in children aged 6 to 11 years. In children, psoriasis affects sensitive areas of thinner skin, so there is a need for a treatment that is safe and well tolerated. The most common adverse events associated with roflumilast, affecting less than 4% of patients, were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. This is the first topical cream indicated to treat psoriasis in sensitive intertriginous areas of the skin.
FOR MORE INFORMATION: arcutis.com