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FDA Approves Drug for the Preventive Treatment of Episodic Migraine in Children Ages 6 Years and Older Who Weigh 45 kg or More

Today, the U.S. Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in pediatric patients who are six years and older and who weigh 45 kg (99 lbs) or more. Ajovy, which was first approved in 2018 for the preventive treatment of migraine in adults, is the first calcitonin gene-related peptide ligand approved for the preventive treatment of episodic migraine in pediatrics. This approval furthers FDA’s longstanding commitment to support treatment options for patients, including pediatrics, and advances in health care for the American public.

Ajovy 225 mg solution is administered subcutaneously (under the skin) once a month. The most common side effects associated with Ajovy include injection site reactions (pain, redness, and itching). Serious side effects including rash, pruritus (itchiness), and drug hypersensitivity were observed. Safety was otherwise similar to what was observed in adult migraine studies.

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