Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a dihydroergotamine (DHE) prefilled syringe autoinjector, intended for the acute treatment of migraine with or without aura and cluster headache in adults. Simultaneously, the company received FDA approval for exenatide, its first generic injectable 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. These developments mark significant advancements in Amneal's strategic initiatives, addressing unmet needs in both migraine and diabetes management.
DHE Autoinjector: A Novel Approach to Migraine Treatment
The DHE autoinjector is designed to offer patients a convenient and effective method for self-administering DHE, a medication commonly used in emergency rooms for severe headaches. Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty, emphasized that this unique product allows patients to self-administer DHE, 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. The autoinjector does not require refrigeration, assembly, or priming, making it easier for patients to use at home during acute attacks. The FDA review of the resubmitted NDA is anticipated to be completed in the second quarter of 2025.
Over 39 million Americans live with migraines, and up to one million suffer from cluster headaches. Headache is also the fourth most common reason for emergency department visits, accounting for 3% of all ER visits in the United States. The DHE autoinjector addresses a significant need for a more accessible and user-friendly treatment option.
The 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.
Generic Exenatide Approved for Type 2 Diabetes
Amneal has also received FDA approval for its generic version of exenatide, available in 1.2 mL and 2.4 mL prefilled pen injection formats, referencing BYETTA®. Exenatide is a GLP-1 agonist used 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, stated that 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.
Patients using exenatide may experience side effects such as changes in kidney function, low blood sugar, and inflammation of the pancreas. Common side effects include nausea, vomiting, diarrhea, dizziness, headache, and weakness.
Strategic Implications for Amneal
The resubmission of the DHE autoinjector NDA and the approval of generic exenatide represent significant milestones for Amneal. The DHE autoinjector targets a $1+ billion migraine market with a differentiated delivery system, while the exenatide approval positions Amneal in the rapidly expanding GLP-1 market, projected to reach $50+ billion by 2025. These developments underscore Amneal's growing expertise in complex pharmaceuticals, peptide development, and drug-device combinations.
