Amneal Progresses With FDA Resubmission For Migraine Autoinjector And Approval Of Diabetes Drug

Amneal Pharmaceuticals, Inc., a global pharmaceutical leader, announced significant progress in two strategic initiatives. The company has resubmitted its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for a dihydroergotamine (DHE) autoinjector designed to treat acute migraines and cluster headaches in adults. Additionally, Amneal received FDA approval for exenatide, marking its first generic injectable glucagon-like peptide-1 (GLP-1) agonist.

Resubmission of DHE Autoinjector NDA

Amneal’s innovative DHE autoinjector offers a ready-to-use, single-dose solution for treating severe headaches, including cluster headaches. Unlike current alternatives, this autoinjector does not require refrigeration or assembly and allows patients to self-administer the medication conveniently at home. DHE, often used in emergency and urgent care, is now available as injectable ampules or a nasal spray for at-home use.

Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty, said, “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 travelling to the emergency room during these painful episodes.”

The FDA had previously issued a complete response letter regarding the original NDA, citing third-party facility issues. Amneal resolved these concerns by transitioning production in-house and utilising its expertise in complex injectables. The FDA is expected to complete its review of the resubmitted application by the second quarter of 2025. This innovation addresses a critical need for the 39 million Americans living with migraines and nearly one million suffering from cluster headaches. Migraine headaches account for almost 3% of emergency visits in the U.S.

FDA Approval of Exenatide Injectable GLP-1 Agonist

The FDA’s approval of exenatide prefilled pens, referencing BYETTA®, showcases Amneal’s capabilities in developing complex pharmaceuticals, including synthetic peptides. Exenatide is indicated for managing type 2 diabetes alongside diet and exercise, and it helps improve glycemic control in adults. Exenatide is available in 1.2 and 2.4 mL prefilled pen injection.

While effective, exenatide may lead to side effects such as nausea, vomiting, low blood sugar, and potential kidney function changes. The approval reflects Amneal’s commitment to expanding access to advanced therapies and addressing patient needs with innovative solutions.

Andy Boyer, Executive Vice President and Chief Commercial Officer of generics, said in statement, “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.” 

These advancements reinforce Amneal’s pharmaceutical innovation and regulatory excellence leader position.