Amneal Pharmaceuticals advances DHE autoinjector resubmission and secures FDA approval for exenatide

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), has achieved two significant milestones, reinforcing its position in the pharmaceutical industry. The company announced the resubmission of its New Drug Application (NDA) for a dihydroergotamine (DHE) prefilled syringe autoinjector for migraines and cluster headaches. At the same time, Amneal Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for exenatide, its first generic glucagon-like peptide-1 (GLP-1) agonist injectable for diabetes.

DHE autoinjector poised to redefine migraine treatment

The DHE autoinjector, a first-of-its-kind product, is designed to address a significant unmet need in the management of migraines and cluster headaches. The single-dose, ready-to-use device offers a convenient alternative to hospital-administered therapies, allowing patients to self-administer during acute episodes without requiring refrigeration or assembly.

Amneal Pharmaceuticals emphasized the transformative potential of the autoinjector for individuals suffering from debilitating headaches, particularly cluster headaches. The product, which utilizes the same active ingredient commonly administered in emergency settings, could significantly reduce reliance on urgent care visits.

Previously, the FDA issued a complete response letter citing deficiencies at a third-party manufacturing site. In response, Amneal Pharmaceuticals shifted production in-house, leveraging its expertise in injectable manufacturing to ensure compliance. The FDA is expected to complete its review of the resubmitted NDA by the second quarter of 2025.

Joe Renda, Senior Vice President and Chief Commercial Officer of Specialty at Amneal Pharmaceuticals, highlighted the product’s ability to empower patients with a reliable, user-friendly solution. He noted that the autoinjector could eliminate the need for emergency room visits during severe headache episodes, offering relief at home.

Migraines impact over 39 million Americans, while cluster headaches affect approximately one million people. With headaches ranking as one of the top reasons for emergency room visits in the United States, the DHE autoinjector could fill a critical gap in patient care.

exenatide approval underscores amneal pharmaceuticals’ innovation

The FDA’s approval of exenatide, a generic equivalent to BYETTA, marks a milestone for Amneal Pharmaceuticals as it enters the competitive GLP-1 agonist market. The injectable medication, indicated for adults with type 2 diabetes, is available in 1.2 mL and 2.4 mL prefilled pen formats.

Exenatide’s approval highlights the company’s ability to develop complex peptide drug-device combinations, which require advanced manufacturing capabilities. Amneal Pharmaceuticals’ entry into the GLP-1 therapeutic space comes at a time when demand for such treatments is surging, driven by their growing role in managing diabetes and obesity.

Andy Boyer, Executive Vice President and Chief Commercial Officer of Generics at Amneal Pharmaceuticals, stated that exenatide represents a significant achievement for the company. He attributed its success to the firm’s investment in innovation and its expertise in developing cost-effective alternatives in high-growth therapeutic categories.

While exenatide provides an affordable option for patients, users should be aware of potential side effects, including nausea, dizziness, and, in rare cases, pancreatitis. The approval positions Amneal Pharmaceuticals to compete in a rapidly growing market dominated by GLP-1 therapies.

strategic outlook for amneal pharmaceuticals

The dual developments signal Amneal Pharmaceuticals’ commitment to expanding its portfolio of complex injectables and addressing unmet medical needs. The resubmission of the DHE autoinjector NDA and the FDA approval of exenatide underscore the company’s ability to innovate and navigate regulatory challenges.

As the migraine and diabetes markets continue to grow, these advancements place Amneal Pharmaceuticals at the forefront of delivering accessible, patient-centric solutions. With regulatory milestones underway and new products entering the market, the company’s trajectory reflects its strategic focus on high-demand therapeutic areas.