(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Ajovy, an injection made by Israeli drugmaker Teva Pharma, to help prevent migraines in children aged six and older who weigh 45 kilograms or more.
This is the first time a drug has been approved for preventing migraines in children.
The injection is given once a month. The most common side effects are pain and redness where the shot is given.
Serious side effects include itchiness, rash and drug hypersensitivity, but the overall safety was similar to what was seen in adult migraine studies, the FDA said.
Episodic migraine refers to recurring severe headaches in children that do not occur daily but are frequent enough to interfere with daily activities.
These headaches are often accompanied by symptoms such as nausea, fatigue and sensitivity to light and sound.
Ajovy is part of a class of drugs called CGRP inhibitors, which block a protein involved in triggering migraines.
The treatment was first approved for adults in 2018 and competes with similar drugs such as Amgen’s Aimovig and Eli Lilly’s Emgality.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Alan Barona)
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