Amneal Resubmits DHE Autoinjector NDA and Gets FDA Approval for Exenatide

Amneal Pharmaceuticals, Inc., a global pharmaceutical organization based in Bridgewater, NJ, has announced significant progress in two strategic projects. The company has resubmitted its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for a new dihydroergotamine (DHE) prefilled syringe autoinjector intended for the acute treatment of migraines, with or without aura, and cluster headaches in adults. In addition, Amneal has secured FDA approval for exenatide, marking their first entry into the generic injectable glucagon-like peptide-1 (GLP-1) agonist market, showcasing their innovative capabilities in peptide drug development and drug-device combinations.

The DHE autoinjector is designed to provide long-lasting pain relief for patients suffering from severe headaches, including cluster headaches. This single-dose, ready-to-use autoinjector offers significant advantages as it does not require refrigeration, assembly, or priming, allowing patients to self-administer the medication at home during painful headaches. Previously, the FDA issued a complete response letter to Amneal’s original NDA due to facility inspection issues at a third-party site. In response, Amneal transferred production in-house, leveraging its expertise in complex injectable manufacturing to complete the product development. The FDA is expected to complete the review of this NDA by the second quarter of 2025.

Joe Renda, Senior Vice President and Chief Commercial Officer - Specialty, expressed enthusiasm about the progress, highlighting the product's potential to offer a ready-to-use solution for patients experiencing severe migraines and cluster headaches. He emphasized that this unique product enables patients to self-administer DHE, a proven therapy, in the comfort of their own homes without the need for emergency room visits during painful episodes.

DHE is typically administered intravenously in emergency rooms, urgent care facilities, and headache clinics. It is also available in ampule form for injection or as a nasal spray for home use. In the United States, over 39 million individuals suffer from migraines, and up to one million experience cluster headaches. Headaches are the fourth most common reason for emergency department visits, accounting for 3% of all ER visits nationwide.

In another significant development, Amneal received FDA approval for exenatide 1.2 mL and 2.4 mL prefilled pen injection, a generic version of BYETTA®. This approval underscores the company's innovation and regulatory prowess in the field of complex pharmaceuticals. Exenatide is a GLP-1 agonist used as an adjunct to diet and exercise to enhance glycemic control in adults with type 2 diabetes mellitus.

Andy Boyer, Executive Vice President and Chief Commercial Officer - Generics, commented on the approval, noting that exenatide represents one of the first generic GLP-1 injectables approved in the U.S. He highlighted the complexity of developing and manufacturing this peptide drug-device combination product and emphasized Amneal’s leading role in the rapidly expanding GLP-1 therapeutic category.

While using exenatide, patients have experienced changes in kidney function, low blood sugar, and pancreas inflammation. The most common side effects include nausea, low blood sugar, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness.

Amneal Pharmaceuticals, Inc. is a global pharmaceutical company headquartered in Bridgewater, NJ. The company focuses on developing, manufacturing, and distributing a diverse portfolio of over 280 generic and specialty pharmaceuticals primarily within the United States. Amneal is expanding its Generics segment across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, the company has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline addressing unmet needs. Through its AvKARE segment, Amneal distributes pharmaceuticals and other products to the U.S. federal government, retail, and institutional markets.