Aug 5 (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 ( AMGN ) Aimovig and
Eli Lilly's ( LLY ) Emgality.