The 89 drugs that have received FDA approval since January 2017, when limiting these drugs’ scope to the drug’s primary indication, suggests significant attention for those patients with migraine. Only those patients with various types of cancer have benefitted more.
Three agents intended to prevent migraine — the injections Aimovig, Ajovy and Emgality — have come in the last 5 months, with the last two receiving the green light within the past 3 weeks.
Kathleen Digre, MD, FAHS, president of the American Headache Society, explained how the migraine-related approvals are particularly extraordinary.
“Not since 1991, when we saw the first triptans approved, has the FDA acted in such rapid succession for patients with migraine. Clearly, this is an exciting time for our patients,” she told Healio Family Medicine.
The flurry of approvals provides new hope for the millions of people who suffer from migraine, a condition the Migraine Research Foundation considers the third most prevalent, and sixth most debilitating, in the world.
All three drugs approved for migraine are monoclonal antibodies and block the activity of the calcitonin gene-related peptide molecule or its receptor that causes the condition. This adds another layer of significance to these new approvals, Digre said.
“Many previous preventive migraine options had dual purposes, such as also working as an antihypertensive or anticonvulsants. Aimovig (erenumab-aooe, Amgen), Ajovy (fremanezumab-vfrm, Teva) and Emgality (galcanezumab-gnlm, Eli Lilly and Company) are almost designer drugs and targeted primarily for migraine. This is thrilling news.”
She warned that the new agents may not be for everyone.
“Depending on a patient’s tolerance level, primary care physicians may want their patients to try other less expensive preventive medications first and then gradually work them up to these new medications if the other treatments don’t work,” Digre said.
“PCPs who have patients need to remember that though trials showed these three drugs are safe and had low side effect profiles, there may be side effects we are not aware of. It behooves all of us that prescribe medications to monitor our patients for any changes in their physical or emotional behaviors,” she added.
Digre, who is also the headache and neuro-ophthalmology division chief at the University of Utah, said that the new medications are only “the tip of the iceberg” in terms of migraine research.
“We don’t completely understand all of the mechanisms behind what causes these types of headaches, so we still need to find that answer. We also know not everyone will respond to erenumab-aooe, fremanezumab-vfrm and galcanezumab-gnlm, so we need to keep researching treatments for these patients,” Digre said.
The milestone year for patients with migraine comes with some caveats, she added.
“I applaud the efforts the manufacturers of these new drugs are taking to make them available to all,” Digre said, referring to Lilly’s decision to offer galcanezumab-gnlm at no cost for up to 1 year for eligible patients.
“I’m cautiously optimistic about people getting access to these medications,” she said. “There are always roadblocks with insurance companies and managed care providers with any treatment, let alone migraine. We need to make sure that we address these barriers so that every patient that can benefit from these medications can do so and we keep health care costs under control.” – by Janel Miller
FDA. Novel Drug Approvals for 2017. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm. Accessed Oct. 4, 2018.
FDA. Novel Drug Approvals for 2018. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm592464.htm. Accessed Oct. 4, 2018.
Humphrey PPA. Headache. 48:685-687.
Lilly. Lilly's Emgality (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults. https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval. Accessed Oct. 4, 2018.
Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed Oct. 3, 2018.
Digre reports no relevant financial disclosures.