Amneal Pharmaceuticals, Inc. has made significant strides in its portfolio, highlighted by the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a dihydroergotamine (DHE) prefilled syringe autoinjector, and the approval of its generic exenatide injectable. The DHE autoinjector is intended for the acute treatment of migraine with or without aura and cluster headache in adults, while exenatide is a glucagon-like peptide-1 (GLP-1) agonist used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
DHE Autoinjector Resubmission
The DHE autoinjector represents a potential breakthrough for patients suffering from severe migraines and cluster headaches. If approved, it would be the first and only DHE autoinjector, providing lasting pain relief with a medication commonly used in hospitals. The single-dose, ready-to-use autoinjector does not require refrigeration, assembly, or priming, allowing patients to self-administer the drug conveniently at home during painful attacks.
The initial NDA received a complete response letter from the FDA due to facility inspection issues at a third-party site. Amneal has since transferred production in-house, leveraging its expertise in complex injectable manufacturing and engineering to complete the product's development. The FDA review is anticipated to be completed in the second quarter of 2025.
"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," said Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty. "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."
Migraines affect over 39 million Americans, while cluster headaches impact up to one million. Headache is also a frequent reason for emergency department visits, accounting for 3% of all ER visits in the United States. The DHE autoinjector aims to provide a more accessible and convenient treatment option compared to current methods, such as intravenous administration in emergency rooms or nasal spray formulations.
Exenatide Approval
Amneal's approval of exenatide 1.2 mL and 2.4 mL prefilled pen injection, referencing BYETTA®, marks one of the first generic GLP-1 injectables approved in the U.S. Exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
"This approval marks one of the first generic GLP-1 injectables to be approved in the U.S," said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. "Exenatide is a peptide drug-device combination product that is complex to develop and make. Amneal is leveraging its leading product development and manufacturing capabilities in the rapidly growing GLP-1 therapeutic category."
Patients using exenatide may experience changes in kidney function, low blood sugar, and inflammation of the pancreas. Common side effects include nausea, low blood sugar, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness.
