Neelam Sharma MS; Lavanya Kundurthy BE; and Hemant N. Joshi, Ph.D., MBA# - Tara Innovations LLC,# [email protected]; www.tara-marketing.com
This quarterly review of New Drug Applications contains data for applications approved during the third quarter of 2023, which includes New Molecular Entities (NMEs) and new biologics. A total of 38 applications were approved by the FDA during these three months.
The NDAs approved during the third quarter of 2023 have been divided into six different dosage forms. Following are the percentages of those dosage forms – injection (50.0%), tablets (28.9%), capsules (5.3%), solution (10.5%), metered dose (2.6%) and oral suspension (2.6%). Recently, there has been more focus on injectable formulations. Following are the submission classifications: BLA (25.6%), Type 1 (new molecular entity, 20.5%), Type 3 (new dosage form, 12.8%), Type 4 (new combination, 15.4%), and Type 5 (new formulation or manufacturer, 25.6%).
Vanflyta (Quizartinib) is an oral FLT3-ITD (FMS-like tyrosine kinase-3- internal tandem duplication) inhibitor for the treatment of patients with FLT3-ITD positive acute myeloid leukemia (AML). AML cancer affects blood and bone marrow. Vanflyta is combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy.
Xdemvy (Lotianer) is used to treat demodex blepharitis. Patients have to instill one drop of Xdemvy in each eye twice daily for six weeks. Demodex is a type of mite that lives in human hair follicles, usually on the face. Blepharitis is an inflammation of eyelids, making them irritated and itchy.
Izervay (Avacincaptad Pegol sodium) is used for treating geographic atrophy (GA). GA is an advanced dry age-related macular degeneration that affects central vision. Izervay is administered as an intra-vitreal injection. It aims to slow down the progression of GA, so vision does not deteriorate as rapidly.
Sohonos (Palovarotene) is used for fibrodysplasia ossificans progressiva (FOP) to decrease the abnormal formation of bone in joints, muscles, tendons, and ligaments. Sohonos is a retinoic acid receptor (gamma) agonist that belongs to a class of medicines known as retinoids.
Aphexda (Motixafortide acetate) is used in the treatment of multiple myeloma, a cancer that forms in plasma cells. Aphexda is used to increase the number of circulating stem cells before they are collected for a stem cell transplant. It is to be used in conjunction with filgrastim (G-CSF) to mobilize hematopoietic stem cells into the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
Ojjaara (Momelotinib) is a Janus Kinase inhibitor that may be used to treat intermediate or high-risk myelofibrosis (MF) in adults with anemia. These enzymes are essential for cytokine signaling (cytokines are small proteins that affect the growth of blood cells and other cells that are involved in inflammation and the immune response).
Rivfloza (Nedosiran sodium) is a lactate dehydrogenase A (LDHA) directed small interfering RNA used to lower urinary oxalate levels in patients with primary hyperoxaluria type 1 (PH1). Rivfloza works in the treatment of PH1 by reducing the levels of hepatic lactate dehydrogenase to reduce the production of oxalate by the liver. Rivfloza is administered by subcutaneous injection once a month.
Publication Details
This article appeared in Pharmaceutical Outsourcing:
Vol. 4, No. 24
Oct/Nov/Dec 2023
Pages: 37-39
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