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Amneal Resubmits FDA Application for Dihydroergotamine Autoinjector

• Amneal Pharmaceuticals has resubmitted its NDA to the FDA for a dihydroergotamine (DHE) prefilled syringe autoinjector, targeting acute migraine and cluster headache treatment. • The resubmission addresses manufacturing concerns raised in a prior rejection, with the FDA expected to complete its review in Q2 2025. • If approved, Amneal's product would be the first DHE autoinjector on the market, offering a convenient, single-dose solution without refrigeration or assembly. • Amneal estimates a $50 million to $100 million US sales opportunity for the autoinjector, given the high prevalence of migraine in American households.

Amneal Pharmaceuticals has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its dihydroergotamine (DHE) prefilled syringe autoinjector, aiming to provide a novel treatment option for acute migraine with or without aura and cluster headache in adults. This resubmission follows a previous rejection due to manufacturing concerns. The FDA is expected to complete its review in Q2 2025.
The initial rejection, communicated through a Complete Response Letter (CRL), stemmed from facility inspection issues at a third-party manufacturing site. Amneal has since addressed these concerns by moving production of the DHE autoinjector in-house.

Addressing Unmet Needs in Migraine Treatment

DHE is a well-established medication for migraines and cluster headaches, currently available as nasal sprays (e.g., Migranal, Trudhesa) and injections (D.H.E. 45). Amneal's autoinjector is designed to be a single-dose, ready-to-use pen that does not require refrigeration, assembly, or priming, offering a more convenient dosing option for patients. One in four households in America has a member with migraine, according to the American Migraine Foundation, highlighting the significant patient population that could benefit from this new delivery method.
Joe Renda, Amneal’s speciality chief commercial officer, stated that the product aims to provide 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.

Market Opportunity

While the existing DHE market makes precise quantification challenging, Amneal estimates a $50 million to $100 million US sales opportunity for its autoinjector, according to a company presentation from June 2024. If approved, Amneal’s product would be the first and only DHE autoinjector available.

Other Regulatory News

In related news, Amneal also announced FDA approval for its generic version of exenatide, an injectable glucagon-like peptide-1 receptor agonist (GLP-1RA), referencing AstraZeneca’s Byetta. This approval covers the 1.2ml and 2.4ml prefilled pen injections.
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Reference News

[1]
Amneal files again for FDA approval of first dihydroergotamine autoinjector
pharmaceutical-technology.com · Nov 22, 2024

Amneal Pharmaceuticals resubmits NDA for DHE autoinjector after FDA rejection, aiming for first market approval. Expecte...

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