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Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist
Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches Exenatide approval highlights Amneal’s capabilities in
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\nPotential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches\n\n\nExenatide approval highlights Amneal’s capabilities in developing GLP-1 injectables\n\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. Second, Amneal has received approval from the FDA for exenatide, which is the Company’s first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations.\n\n\nResubmission of DHE Autoinjector New Drug Application\nThis first and only DHE autoinjector has the potential to provide patients with lasting pain relief from tough-to-treat headaches, particularly cluster headaches, with the same powerful medication used in hospitals. The single-dose, ready-to-use autoinjector will not require refrigeration, assembly, or priming, and allow patients to conveniently self-administer at home when experiencing painful attacks.\n\n\nThe U.S. FDA previously issued a complete response letter to the original NDA, citing facility inspection issues at a third-party site. As a result, Amneal transferred production to in-house and leveraged its expertise in complex injectable manufacturing and engineering to complete development of this new product. The review of this NDA is expected to be completed in the second quarter of 2025.\n\n\n“We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches. This is a unique product that can allow patients to self-administer DHE, which is a proven therapy that provides lasting relief for tough-to-treat headaches, in a single-dose autoinjector without the need for assembly or traveling to the emergency room during these painful episodes,” said Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty.\n\n\nDHE is commonly administered in emergency rooms, urgent care facilities, ...