Friday, September 28, 2018

Two More CGRP-Drugs Approved by FDA

May 17, 2018 was a Momentous Day for Migraine: First CGRP-Drug Approved by FDA. It was the first FDA approval in a new class of preventive medications developed specifically for migraine.

The month of September has seen the FDA approve two more CGRP-related medications.

On September 14, Teva announced the FDA approval of Ajovy (fremanezumab-vfrm), "a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor" (https://www.businesswire.com/news/home/20180914005613/en/). It's available in monthly or quarterly doses, via self-administered, subcutaneous injection(s) from pre-filled syringe(s). The list price is $575 per monthly dose and $1,725 per quarterly dose.

On September 27, Eli Lilly and Company announced the FDA approval of Emgality (galcanezumab-gnlm). It will be available as a once monthly, self-administered, subcutaneous injection. The first month will be two injections, followed by a single monthly injection.(https://www.multivu.com/players/English/8386051-lilly-emgality-fda-approval-migraine-treatment/)

The CGRP class of medications work to stop CGRP protein from binding to the receptor. Aimovig, is a monoclonal antibody against the CGRP receptor. Both Ajovy and Emgality are monoclonal antibodies against the CGRP protein. There is one more medication that targets the protein that has not yet been approved by the FDA.

Further reading:

Each of the companies that have come to market with CGRP medications for migraine prevention are offering patient support programs, specifically for those with commercial insurance.

Here are the links for the different medications that have been FDA approved:

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