Galcanezumab Approved for Migraine Treatment

New treatment, galcanezumab (Emgality™), designed to inhibit CGRP, reduce migraine frequency

Eli Lilly and Company announced late September 2018 that the U.S. Food and Drug Administration had approved galcanezumab (Emgality™) for preventive migraine treatment in adults. This announcement comes a week after the FDA approved Teva Pharmaceutical’s fremanezumab-vfrm (AJOVY™) for migraine treatment, making it the third anti-CGRP treatment on the market.

“The need for improved preventive treatment has been a long-standing priority,” said American Migraine Foundation Director Nim Lalvani. “These breakthrough treatments in the anti-CGRP class provide much-needed hope for our community of patients living with migraine.”

What is CGRP?

CGRP is a protein known for causing the pain in migraine, and all three FDA-approved treatments rely on monoclonal antibodies designed to target CGRP or its receptor in trigeminal pain pathways. These molecules are too large to cross into the brain to any significant degree and are not metabolized by the liver or excreted by the kidneys. That means minimal chance of adverse effects on the liver or kidney and no interactions with other drugs. Clinical trials also found minimal side effects.

Patients starting galcanezumab begin with two consecutive subcutaneous injections of 120 milligrams each as a loading dose, before beginning self-administered, monthly doses of 120 milligrams. The U.S. list price of galcanezumab is $575 once monthly, or $6,900 annually. Patients with commercial insurance may be eligible to receive the drug for up to 12 months free as part of Eli Lilly’s patient-support program.

“The approval of these new anti-CGRP medications is reason to be optimistic about migraine awareness and migraine treatment,” said Dr. Lawrence Newman, MD, FAHS, American Migraine Foundation Vice Chair and Headache Division Director at NYU Langone Health. “We believe that the availability of new therapies provides patients a range of options that suit their lifestyles and needs.”

CGRP inhibitors are the first drugs specifically approved for migraine prevention in more than 50 years, making this a golden era of headache medicine. People living with migraine can now access three different therapies designed specifically for their disease, with more options and new possibilities for treatment on the horizon.