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Home Health & Science Biotechnology & Pharma

FDA approves Amneal’s self-administered migraine drug Brekiya

swissnewspaper by swissnewspaper
21 May 2025
Reading Time: 2 mins read
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FDA approves Amneal’s self-administered migraine drug Brekiya


Brekiya is now the primary DHE auto-injector to be authorized by the regulator

The US Meals and Drug Administration (FDA) has authorized Amneal Prescribed drugs’ Brekiya (dihydroergotamine mesylate) injection to deal with acute migraine and cluster complications in adults.

The remedy, which is anticipated to be out there for eligible sufferers within the second half of 2025, is now the primary dihydroergotamine (DHE) auto-injector to be authorized by the regulator.

Headache issues are among the many commonest issues of the nervous system, based on the World Well being Group. Affecting roughly 39 million individuals within the US, migraines normally final between 4 and 72 hours and are related to signs reminiscent of a throbbing ache, nausea, vomiting, and elevated sensitivity to gentle and sound.

Cluster complications are much less frequent, occurring in round a million individuals within the US. The situation is characterised by regularly recurring, temporary however extraordinarily extreme complications, normally targeted in or round one eye.

Usually given intravenously in emergency rooms and pressing care amenities, DHE is a fast-acting remedy that may assist relieve migraine assaults and will shield sufferers from headache recurrence.

Amneal’s Brekiya injection will now give sufferers the choice to self-administer the identical drug utilized in hospitals in a ready-to-use system.

Sufferers can ship one dose subcutaneously into the center of their thigh, and the autoinjector doesn’t require refrigeration or meeting.

Joe Renda, Senior Vice President, Chief Industrial Officer – Specialty, stated: “Physicians are aware of DHE, which is an efficient and well-established remedy that gives sustained reduction for complications.

“Our single-dose auto-injector represents an modern therapeutic possibility for sufferers that enables for fast self-administration of the remedy throughout these painful assaults with out visiting the emergency room.”

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Brekiya is now the primary DHE auto-injector to be authorized by the regulator

The US Meals and Drug Administration (FDA) has authorized Amneal Prescribed drugs’ Brekiya (dihydroergotamine mesylate) injection to deal with acute migraine and cluster complications in adults.

The remedy, which is anticipated to be out there for eligible sufferers within the second half of 2025, is now the primary dihydroergotamine (DHE) auto-injector to be authorized by the regulator.

Headache issues are among the many commonest issues of the nervous system, based on the World Well being Group. Affecting roughly 39 million individuals within the US, migraines normally final between 4 and 72 hours and are related to signs reminiscent of a throbbing ache, nausea, vomiting, and elevated sensitivity to gentle and sound.

Cluster complications are much less frequent, occurring in round a million individuals within the US. The situation is characterised by regularly recurring, temporary however extraordinarily extreme complications, normally targeted in or round one eye.

Usually given intravenously in emergency rooms and pressing care amenities, DHE is a fast-acting remedy that may assist relieve migraine assaults and will shield sufferers from headache recurrence.

Amneal’s Brekiya injection will now give sufferers the choice to self-administer the identical drug utilized in hospitals in a ready-to-use system.

Sufferers can ship one dose subcutaneously into the center of their thigh, and the autoinjector doesn’t require refrigeration or meeting.

Joe Renda, Senior Vice President, Chief Industrial Officer – Specialty, stated: “Physicians are aware of DHE, which is an efficient and well-established remedy that gives sustained reduction for complications.

“Our single-dose auto-injector represents an modern therapeutic possibility for sufferers that enables for fast self-administration of the remedy throughout these painful assaults with out visiting the emergency room.”

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Brekiya is now the primary DHE auto-injector to be authorized by the regulator

The US Meals and Drug Administration (FDA) has authorized Amneal Prescribed drugs’ Brekiya (dihydroergotamine mesylate) injection to deal with acute migraine and cluster complications in adults.

The remedy, which is anticipated to be out there for eligible sufferers within the second half of 2025, is now the primary dihydroergotamine (DHE) auto-injector to be authorized by the regulator.

Headache issues are among the many commonest issues of the nervous system, based on the World Well being Group. Affecting roughly 39 million individuals within the US, migraines normally final between 4 and 72 hours and are related to signs reminiscent of a throbbing ache, nausea, vomiting, and elevated sensitivity to gentle and sound.

Cluster complications are much less frequent, occurring in round a million individuals within the US. The situation is characterised by regularly recurring, temporary however extraordinarily extreme complications, normally targeted in or round one eye.

Usually given intravenously in emergency rooms and pressing care amenities, DHE is a fast-acting remedy that may assist relieve migraine assaults and will shield sufferers from headache recurrence.

Amneal’s Brekiya injection will now give sufferers the choice to self-administer the identical drug utilized in hospitals in a ready-to-use system.

Sufferers can ship one dose subcutaneously into the center of their thigh, and the autoinjector doesn’t require refrigeration or meeting.

Joe Renda, Senior Vice President, Chief Industrial Officer – Specialty, stated: “Physicians are aware of DHE, which is an efficient and well-established remedy that gives sustained reduction for complications.

“Our single-dose auto-injector represents an modern therapeutic possibility for sufferers that enables for fast self-administration of the remedy throughout these painful assaults with out visiting the emergency room.”

Buy JNews
ADVERTISEMENT


Brekiya is now the primary DHE auto-injector to be authorized by the regulator

The US Meals and Drug Administration (FDA) has authorized Amneal Prescribed drugs’ Brekiya (dihydroergotamine mesylate) injection to deal with acute migraine and cluster complications in adults.

The remedy, which is anticipated to be out there for eligible sufferers within the second half of 2025, is now the primary dihydroergotamine (DHE) auto-injector to be authorized by the regulator.

Headache issues are among the many commonest issues of the nervous system, based on the World Well being Group. Affecting roughly 39 million individuals within the US, migraines normally final between 4 and 72 hours and are related to signs reminiscent of a throbbing ache, nausea, vomiting, and elevated sensitivity to gentle and sound.

Cluster complications are much less frequent, occurring in round a million individuals within the US. The situation is characterised by regularly recurring, temporary however extraordinarily extreme complications, normally targeted in or round one eye.

Usually given intravenously in emergency rooms and pressing care amenities, DHE is a fast-acting remedy that may assist relieve migraine assaults and will shield sufferers from headache recurrence.

Amneal’s Brekiya injection will now give sufferers the choice to self-administer the identical drug utilized in hospitals in a ready-to-use system.

Sufferers can ship one dose subcutaneously into the center of their thigh, and the autoinjector doesn’t require refrigeration or meeting.

Joe Renda, Senior Vice President, Chief Industrial Officer – Specialty, stated: “Physicians are aware of DHE, which is an efficient and well-established remedy that gives sustained reduction for complications.

“Our single-dose auto-injector represents an modern therapeutic possibility for sufferers that enables for fast self-administration of the remedy throughout these painful assaults with out visiting the emergency room.”

Tags: AmnealsapprovesBrekiyaDrugFDAmigraineselfadministered
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