Another Indication for Rinvoq
On April 29, 2025, the US Food and Drug Administration (FDA) approved AbbVie’s Rinvoq® (upadacitinib) for the treatment of adults with giant cell arteritis (GCA). Sometimes called temporal arteritis because it mainly affects arteries in the head and neck, GCA is an autoimmune disease that involves inflammation of the linings of the arteries that can lead to blindness, aortic aneurysm or stroke. In studies, 46.4% of patients achieved remission with Rinvoq 15mg once daily compared to 29% in the control group at 52 weeks, which was statistically significant. Initially, it will be given along with a corticosteroid, but the steroid dose will decrease gradually until it is stopped. An oral Janus Kinase (JAK) inhibitor, Rinvoq is approved to treat rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), polyarticular juvenile idiopathic arthritis, Crohn’s disease (CD), ulcerative colitis (UC), non-radiographic axial spondyloarthritis (nr-axSpA) and atopic dermatitis. A boxed warning outlines the increased risks of blood clots, cancer, cardiovascular events and serious infections that may be associated with the use of any JAK inhibitor, including Rinvoq. Patients taking one of the drugs in the class also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Look here for Rinvoq’s current prescribing information.
New Dosage Form of Thiotepa Approved
Shorla Oncology received FDA approval for Tepylute® (thiotepa) 100mg/10mL multi-dose vials on April 29, 2025. This is a multi-dose, ready-to-dilute formulation of the alkylating drug, which is used to treat adenocarcinoma of the breast or ovary. This form eliminates the need for reconstitution as currently available forms of thiotepa are supplied as lyophilized powder formulations that need to be reconstituted with sterile water prior to dilution with sodium chloride. This formulation is also stable for 14 days after opening. Tepylute comes with a boxed warning that it can cause a decrease in bone marrow activity resulting in decreased red blood cells, white blood cells and platelets. It also carries a boxed warning indicating an elevated risk of developing secondary cancers. Launch date and pricing information are not available at this time. Updated prescribing information is available here.
Atzumi Nasal Powder Approved for Acute Migraine Treatment
Satsuma Pharmaceuticals gained FDA approval for Atzumi™ [dihydroergotamine (DHE)] nasal powder on April 30, 2025, for the acute treatment of migraine with or without aura in adults. Although various forms of DHE have been used for decades to treat migraines, oral absorption is erratic, and injectable forms are not always convenient to use. Two intranasal sprays are available, Migranal® and generics and Trudhesa®; however, Atzumi is a dry-powder nasal formulation administered using a proprietary nasal delivery device designed to provide fast absorption of DHE in the nasal passages. The recommended dose is 5.2mg administered into one nostril by squeezing the white air pump of the device three separate times into one nostril. The dose may be repeated one hour after the first dose if needed. A boxed warning on all DHE products explains that using it while taking some other drugs, such as some antibiotics, antifungals and antivirals, may increase the risk of interrupted blood flow in the brain or the hands and feet. The cardiovascular health of potential patients should be evaluated before treatment. Here is the prescribing information.