Amneal obtains FDA OK for generic Byetta, resubmits DHE NDA
Amneal announced the advancement of two key strategic initiatives.
Amneal has received approval from the Food and Drug Administration for exenatide, which is the company’s first generic injectable glucagon-like peptide-agonist and reflects its innovation capabilities in peptide development and drug-device combinations.
The approval of exenatide 1.2 ml and 2.4 ml prefilled pen injection, referencing Byetta, reflects the company’s deep innovation and regulatory capabilities in complex pharmaceuticals and its ability to successfully develop this first synthetic generic peptide, Amneal said. Exenatide is a GLP-1 agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
“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,” said Andy Boyer, executive vice president, chief commercial officer of generics at Amneal.
[Related: Amneal touts 39 retail, injectable product launches in 2023]
Amneal also announced that it has resubmitted to the FDA its new drug application for dihydroergotamine prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults.
This first and only DHE autoinjector has the potential to provide patients with lasting pain relief from tough-to-treat headaches, particularly cluster headaches, with the same powerful medication used in hospitals. The single-dose, ready-to-use autoinjector will not require refrigeration, assembly, or priming and allow patients to conveniently self-administer at home when experiencing painful attacks, Amneal said.
The 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. The review of this NDA is expected to be completed in the second quarter of 2025.
[Read more: Amneal expands injectables portfolio with 6 new therapies]
“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 traveling to the emergency room during these painful episodes,” said Joe Renda, senior vice president, chief commercial officer of specialty.
DHE is commonly administered in emergency rooms, urgent care facilities and headache clinics intravenously. Currently, DHE also is available both as ampules for injection or as a nasal spray formulation for at-home use. Over 39 million Americans are living with migraines, and up to one million with cluster headaches. Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States, Amneal noted.