Reyvow – approved and ready to launch

Creates a new class of drugs to treat migraines.

October 15, 2020

At Prime, we get ahead of drug trends to prepare for new drugs entering the market.

Drug: Reyvow (lasmiditan)
Manufacturer: Eli Lilly
Condition: For acute treatment of migraine headaches
Approved: Approved October 11, 2019

Eli Lilly’s Reyvow™ (lasmiditan) received FDA approval on Oct. 11, 2019 for the acute treatment of migraine with or without aura in adults. It is the first serotonin receptor agonist to target the 5-HT1F receptor. It has created a new class of drugs, which will be referred to as ‘ditans.’3 ‘Ditans’ differ from triptans in their method of action, triptans are 5-HT(1B/1D) serotonin receptor agonists.

Condition overview4-7

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.

Current treatments1-4

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 that 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, and are available in various dosage forms including pills, nasal sprays and subcutaneous injection. Response rates to triptans may decrease over time.2 The new acute migraine treatments like Reyvow and the CGRP receptor agonists, may be recommended after triptans fail or if a patient cannot tolerate a triptan.

Reyvow overview

Reyvow is the first drug in a new class of migraine medications called serotonin-1F receptor agonists, or ditans. It may be used for some migraine patients who cannot take triptans due to the risk of comorbidities, or coronary artery disease, hypertension and stroke. (Triptan’s mechanism of action constricts certain blood vessels.) In clinical trials, Reyvow was found to improve migraine symptoms within two hours compared to placebo, and side effects were generally mild to moderate.

Eli Lilly noted that there is a potential for abuse of Reyvow. The recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of the FDA’s approval, after which the drug will be available to patients in retail pharmacies.5

Drug: Reyvow (lasmiditan)
ROA: Oral
Condition: For acute treatment of migraine headaches
Approved: Approved Oct. 11, 2019
Benefit: Reyvow will impact the pharmacy benefit

Prime monitors the drug pipeline

The drug pipeline is full of new, groundbreaking specialty drugs that may help members live better and feel well. Prime focuses on clinical strategies designed to keep clients ahead of drug trends — because it’s easier to manage change when you see it coming.

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. Durham P, Vause C. CGRP Receptor Antagonists in the Treatment of Migraine. CNS Drugs. 2010;24(7):539–548.

4. UpToDate. Acute migraine. Literature review current through April 2019. Last updated December 11, 2018.

5. https://investor.lilly.com/news-releases/news-release-details/lillys-reyvowtm-lasmiditan-first-and-only-medicine-new-class

6. Icer-review.org Acute treatments for migraine: effectiveness and value. Revised Background and Scope July 29, 2019. ICER Institute for clinical and economic review. Accessed in September 2019 at: https://icer-review.org/wp-content/uploads/2019/06/ICER_Acute_Migraine_Revised_Scope_072919-1.pdf)

Related research

Drug pipeline updates

October 14, 2021

November 2021 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to…

Drug pipeline updates

September 30, 2021

Drug Pipeline Quarterly Update: September 2021

These quarterly pipeline wrap-ups include new molecular entity approvals, drugs with approvable status…

Drug pipeline updates

September 12, 2021

October 2021 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to…