Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) announced two major developments: the resubmission of its NDA for a DHE autoinjector for migraine and cluster headache treatment, and FDA approval of exenatide, its first generic injectable GLP-1 agonist. The DHE autoinjector would be the first and only of its kind, offering at-home self-administration without refrigeration or assembly. The FDA review is expected by Q2 2025. The exenatide approval (1.2 mL and 2.4 mL prefilled pens) demonstrates Amneal's capabilities in complex pharmaceuticals and peptide development, targeting type 2 diabetes treatment.

Positive

• First-to-market opportunity with unique DHE autoinjector product
• FDA approval received for exenatide, entering the growing GLP-1 market
• In-house manufacturing capability for complex injectables
• Large market potential with 39 million Americans living with migraines

Negative

• Previous FDA complete response letter due to facility inspection issues
• Long regulatory timeline with DHE review expected in Q2 2025
• Common side effects reported with exenatide including kidney function changes

Insights

Pharmaceutical Industry Analyst

The dual announcement represents significant progress in Amneal's strategic initiatives. The DHE autoinjector resubmission addresses a $1+ billion migraine market with a differentiated delivery system that could capture significant market share due to its convenience and self-administration benefits. The timing aligns well with market dynamics, though the Q2 2025 review timeline means delayed revenue impact.

The exenatide approval is particularly noteworthy as one of the first generic GLP-1 agonists in the U.S. With the GLP-1 market projected to reach $50+ billion by 2025, even a small market share could translate to meaningful revenue. This approval validates Amneal's complex generics capabilities and positions them well for future peptide drug development.

Medical Device Expert

The DHE autoinjector's design features address key patient needs in migraine treatment. The elimination of refrigeration requirements and priming steps significantly improves upon existing options. The in-house manufacturing transfer demonstrates strong technical capabilities and could improve margins compared to third-party manufacturing.

The successful development of both autoinjector platforms showcases Amneal's growing expertise in drug-device combinations, particularly valuable as the industry moves toward more self-administered therapeutics. This technical foundation could support future product development in high-value therapeutic areas.

Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches

Exenatide approval highlights Amneal’s capabilities in developing GLP-1 injectables

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. Second, Amneal has received approval from the FDA for exenatide, which is the Company’s first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations.

Resubmission of DHE Autoinjector New Drug Application
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.

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. The review of this NDA is expected to be completed in the second quarter of 2025.

“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 - Specialty.

DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. Currently, DHE is also available both as ampules for injection or as a nasal spray formulation for at-home use. Over 39 million Americans are living with migraines⁽¹⁾, and up to one million with cluster headaches.⁽²⁾ Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States.⁽³⁾

U.S. FDA Approval of Exenatide, an Injectable GLP-1 Agonist
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. 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 - Generics.

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

For complete prescribing information, please refer to the package insert available here.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

References
(1) https://migraineresearchfoundation.org/about-migraine/migraine-facts/
(2) https://americanmigrainefoundation.org/resource-library/cluster-headache-2/
(3) Zodda D, Procopio G, Gupta A. Evaluation and management of life-threatening headaches in the emergency department. Emerg Med Pract. 2019 Feb;21(2):1-20. Epub 2019 Feb 1. PMID: 30676714. https://pubmed.ncbi.nlm.nih.gov/30676714/

View source version on businesswire.com: https://www.businesswire.com/news/home/20241121053036/en/

Amneal Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

When will Amneal's DHE autoinjector for migraines receive FDA review decision?

The FDA review of Amneal's (AMRX) DHE autoinjector NDA is expected to be completed in the second quarter of 2025.

What dosage strengths did Amneal receive FDA approval for exenatide?

Amneal (AMRX) received FDA approval for exenatide in 1.2 mL and 2.4 mL prefilled pen injection formats.

What advantages does Amneal's DHE autoinjector offer over current treatments?

Amneal's (AMRX) DHE autoinjector will be the first single-dose, ready-to-use option that doesn't require refrigeration, assembly, or priming, allowing convenient self-administration at home.

What is the market size for Amneal's DHE autoinjector treatment?

The potential market includes over 39 million Americans living with migraines and up to one million with cluster headaches.