Amneal Pharmaceuticals has announced significant progress in its portfolio with the resubmission of its New Drug Application (NDA) for a dihydroergotamine (DHE) autoinjector and the FDA approval of its generic exenatide. These developments underscore Amneal's commitment to addressing unmet needs in migraine and type 2 diabetes treatment.
DHE Autoinjector Resubmission for Migraine and Cluster Headaches
Amneal's resubmitted NDA seeks approval for a DHE prefilled syringe autoinjector designed for the acute treatment of migraine with or without aura and cluster headache in adults. This autoinjector offers a potential alternative to current DHE administration methods, which often require intravenous delivery in clinical settings. The single-dose, ready-to-use device eliminates the need for refrigeration, assembly, or priming, allowing for convenient self-administration at home.
The initial NDA received a complete response letter from the FDA due to facility inspection issues at a third-party manufacturing site. Amneal has since transferred production in-house, leveraging its expertise in complex injectable manufacturing to address the FDA's concerns. The review of the resubmitted NDA is anticipated to be completed in the second quarter of 2025.
Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty, stated, "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."
Migraine affects over 39 million Americans, while cluster headaches impact up to one million. Headache is also a frequent cause for emergency department visits, accounting for 3% of all ER visits in the United States. The DHE autoinjector has the potential to reduce the burden on emergency services by providing a readily accessible treatment option for patients experiencing severe headache episodes.
FDA Approves Generic Exenatide for Type 2 Diabetes
In addition to the DHE autoinjector resubmission, Amneal has received FDA approval for its generic exenatide, referencing BYETTA®. Exenatide is a glucagon-like peptide-1 (GLP-1) agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics, commented, "This approval marks one of the first generic GLP-1 injectables to be approved in the U.S. 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."
Common side effects associated with exenatide use include nausea, low blood sugar, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness. Patients have also experienced changes in kidney function and inflammation of the pancreas while using exenatide. The prescribing information is available here.
