Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals

Amneal Pharma, a global leader in pharmaceuticals, today announced the progression of two significant strategic initiatives. Firstly, the company has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the dihydroergotamine (DHE) prefilled syringe autoinjector, aimed at the acute treatment of migraines with or without aura, and cluster headaches in adults. Secondly, Amneal has received FDA approval for exenatide, marking its first generic injectable glucagon-like peptide-1 (GLP-1) agonist.

Publish Date: 21-11-2024 Source: Amneal Pharmaceuticals, Inc.

Cluster Headaches are the most prevalent form of trigeminal autonomic cephalgias (TACs), a group of primary headache disorders. Risk factors include male gender, age over 30, alcohol consumption, and a history of brain surgery or trauma. The stages of classification include Episodic, Chronic, and Probable. Patients should undergo magnetic resonance imaging (MRI) or computed tomography (CT) with contrast to exclude structural abnormalities. It’s crucial to also assess for pituitary abnormalities, as a notable portion of individuals with prolactinomas or growth hormone tumors may manifest with TACs. Treatment for cluster headaches involves addressing acute attacks and implementing preventive measures. In the acute phase, 100% oxygen therapy is widely recognized as the primary treatment. For prevention, a suboccipital blockade stands out as the only level A suggested treatment for cluster headache prevention.

Its lifetime prevalence is estimated to be 124 per 100,000 persons, with a one-year prevalence of 53 per million.

However, the current Cluster Headache treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (C213, Eptinezumab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Cluster Headache treatment. The key companies in the advanced development stage are Zosano Pharma Corporation, H. Lundbeck A/S, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Cluster Headache to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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