FDA issues its first approval for an oral CGRP formulation for migraine

Ubrelvy™ (ubrogepant) received FDA approval on Dec. 23, 2019, for treatment of migraine.

Drug: Ubrelvy (ubrogepant)
ROA: Oral
Manufacturer: Allergan
Condition: For treatment of migraine
Approved: 12/23/19

Condition overview

Migraine headaches are common in the United States, affecting nearly 1 out of 7 Americans annually. A migraine is a recurring, severe, throbbing headache that’s usually on one side of the head. Migraine attacks can last for a few hours, or a few days. Other symptoms can include nausea, vomiting, and extreme sensitivity to light and sound. Flashes of light or blind spots may happen before or during the headache. Tingling on one side of your face, or in your arm or leg, can also occur.

One or two days before the migraine, you may have warning signs including constipation, mood changes, food cravings, neck stiffness, increased thirst and urination and frequent yawning.2

Current treatments

Pain-relieving medications. Also known as acute or abortive treatment, these drugs are taken during migraine attacks to stop symptoms.2
Preventive medications. These drugs are taken regularly, sometimes daily, to reduce the severity or frequency of migraines.2
Choice of medicine depends on the frequency and severity of headaches, the degree of disability they cause, and other medical conditions.2 Patients who experience mild symptoms may be treated with over-the counter pain medications, often used in combination with caffeine.

Acute migraine attacks can be treated with triptans, ergotamine, butalbital combination products and opioids. Triptans are the current standard of care for acute treatment for moderate-to-severe symptoms of migraine; they’re available in various dosage forms including pills, nasal sprays and subcutaneous injection. Response rates to triptans may decrease over time.

A new class of drugs emerged in 2018 for the prevention of migraine – selective calcitonin gene-related peptide (CGRP) antagonists. The first three drugs approved in this class were:

• Ajovy® (fremanezumab-vfrm) from Teva Pharmaceuticals
• Emgality® (galcanezumab-gnlm) from Eli Lilly
• Aimovig® (erenumab-aooe) from Novartis and Amgen

All three drugs above are taken monthly by subcutaneous injection. Ubrelvy provides the first oral CGRP formulation for migraine.

Overview of CGRPs

CGRP is a protein released around the brain. When CGRP is released, it causes intense inflammation in the coverings of the brain (the meninges). For most migraine patients, this causes the pain of a migraine attack.3 CGRP levels rise during migraine pain and are normal when pain reduces. CGRP antagonists prevent the production of the protein or the receptors it attaches to.3

Summary of Ubrelvy

Ubrelvy is the first oral CGRP formulation approved for treatment of migraine in adults.1

In a Jan. 10 post on FirstWord Pharma, David Rind, MD, ICER’s Chief Medical Officer said: “These new [CGRP] therapies appear to be less effective overall than triptans and are expected to be much more expensive. However, for those patients who are unable to take triptans or who don’t get adequate benefit from them, the evidence does demonstrate that all three new therapies [lasmiditan (Reyvow™, Eli Lilly), rimegepant (Biohaven), and ubrogepant (Ubrelvy™, Allergan)] improve or relieve migraine symptoms in 10-20% more patients than respond to placebo.

“To reach commonly cited thresholds of cost-effectiveness, these therapies would require prices significantly below what some analysts are currently projecting,” Rind added.4

A second oral CGRP receptor antagonist, rimegepant from Biohaven, has an expected PDUFA date in February 2020.

Reyvow (lasmiditan), from Lilly, is the first serotonin receptor agonist to target the 5-HT1F receptor to treat acute migraines. Due to its potential for abuse and dependence, it requires DEA review for controlled substance classification prior to launch. It is expected to launch in January 2020 after DEA scheduling.

Benefit: Both Ubrelvy and Reyvow will impact the pharmacy benefit.

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References

1. Burch, RC, et al. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. (2015.) – PubMed – NCBI. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25600719

2. Migraine – Symptoms and causes. Mayo Clinic. (April 26, 2017). Retrieved from https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201

3. What to Know About the New Anti CGRP Migraine Treatment Options, American Migraine Foundation. Accessed at: https://americanmigrainefoundation.org/resource-library/what-to-know-about-the-new-anti-cgrp-migraine-treatment-options/

4. ICER Releases Evidence Report on Acute Treatments for Migraine, Jan. 10, 2020. First Word Pharma. © 2020 Doctor’s Guide Publishing Limited. Accessed on January 13, 2020. http://www.firstwordpharma.com/node/1692730?tsid=2#axzz6AubOiQ2i