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etvfutures.com May 24, 2018


USA approves first drug developed to prevent chronic migraines

18 May 2018, 04:41 | Lena Norman

The FDA has approved the first drug to prevent migraines

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A new medicine that is created to prevent the onset of a migraine was approved by the Food and Drug Administration on Thursday.

The drug is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide ("CGRP") receptor.

Amgen (AMGN) was first to the finish line late Thursday with a drug created to prevent migraines by blocking a specific receptor - leading Eli Lilly (LLY), Teva Pharmaceutical (TEVA) and Alder Biopharmaceuticals (ALDR). "We need new treatments for this painful and often debilitating condition".

In a study, patients who were administered with the Aimovig shot saw that their migraine days were reduced from eight days to four days in a month on an average.

The FDA's approval of Aimovig (erenumab-aooe) was based on data from three clinical trials - the first involved 955 participants with a history of episodic comparing Aimovig with placebo.

Earlier in the week, Eli Lilly and Company (Indianapolis) announced that its CGRP monoclonal antibody, galcanezumab, met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, which represents 85 to 90 percent of cluster headache cases, according to a company release. In the second (n=577) and third (n=667) studies, in which patients had a history of chronic migraine, subjects experienced one fewer migraine day and 2-1/2 fewer migraine days, per month on average, respectively.

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Before the trial, patients had about 18 migraine days.

The two companies, Novartis and Amgen, are also collaborating on associated "The Aimovig Ally Product Support Program". However, most of the migraine patients avoid using these treatments as they do not help them get enough relief or tend to cause severe side effects.

The approval for sale in the European Union is expected in the next few months. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications. The Teva CGRP antibody is now under FDA review for preventive migraine in adults.

Aimovig and the migraine drugs in development target a substance called CGRP whose levels spike in the blood during a migraine, triggering symptoms.

Aimovig is the first in a new class of treatments created to prevent a migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain.



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