This quarterly review on New Drug Applications contains data for applications approved during the fourth quarter of 2023, which includes New Molecular Entities (NMEs) and new biologics. A total of 39 applications were approved by the FDA during these three months.
The NDAs approved during the fourth quarter of 2023 have been divided into nine different dosage forms. Following are the percentages of those dosage forms – injection (38.5%), tablets (33.3%), capsules (10.3%), topical gel (5.13%), and 2.56% each for ophthalmic solution, topical foam, oral pellets, oral suspension, and intracameral (anterior chamber of eyeball) implant. Recently, there has been more focus on injectable formulations. Following are the submission classifications: BLA (19.5%), Type 1 (New molecular entity, 26.8%), Type 2 (New active ingredient, 4.9%), Type 3 (New dosage form, 19.5%), Type 4 (New combination, 12.2%), Type 5 (New formulation or manufacturer, 9.8%) and Type 10 (New indication submitted as Distinct NDA – not consolidated, 7.3%).
Novartis is a global leader in immuno-dermatology and rheumatology. On October 6, 2023, the U.S. FDA approved an intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). This is the only treatment approved in an IV form. Cosentyx is a fully human biologic that specifically targets and blocks interleukin-17A (IL-17A), an important cytokine involved in inflammation.
Zymfentra® is the first and only FDA-approved subcutaneous (SC) formulation of infliximab. This is approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease. The infliximab biosimilar developed and manufactured by Celltrion was the world's first monoclonal antibody biosimilar. It is indicated for the treatment of eight autoimmune diseases.
Ionis Pharmaceuticals, Inc. received FDA approval for Ionis, and AstraZeneca's Wainua™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. ATTRv-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade. Wainua™ is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.
Eli Lilly and Company received FDA approval for Zepbound™ (tirzepatide) injection, a powerful new option for the treatment of obesity or overweight with weight-related medical problems. This activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
Tenapanor HCl tablets (Ibsrela, 50 mg) were approved on September 12, 2019 to treat irritable bowel syndrome with constipation. Tenapanor HCl is a sodium hydrogen exchanger 3 inhibitor. Recently, it was approved as 10, 20, and 30 mg tablets as a first-in-class phosphate absorption inhibitor. On the same line, Vonoprazan with antibiotics was approved in May 2022 to treat gastroduodenal ulcers and eradicate Helicobacter pylori. Recently, it was approved (Voquenzna, 10 and 20 mg tablets) to treat gastroesophageal reflux disease (GERD).
Author Details
Neelam Sharma MS; Lavanya Kundurthy BE; and Hemant N. Joshi, Ph.D., MBA# - Tara Innovations LLC, #[email protected], www.tarainnovations.com
Publication Detail
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No. 1Jan/Feb/Mar 2024Pages: 42-44
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!