FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades

Eli Lilly won FDA approval for a migraine drug on Friday, giving the pharmaceutical giant a second medication that addresses the condition that causes millions of people to experience severe headaches and other debilitating symptoms.

The FDA approved the drug, lasmiditan (Reyvow), as a treatment for acute migraine; it’s meant to be taken after the onset of migraine pain. That pain can be with or without aura—flashes of light, blind spots, and tingling sensations that sometimes accompany a migraine attack. According to data from two Phase 3 tests, the FDA said that the Lilly (NYSE: LLY) drug beat a placebo in resolving migraine pain two hours after treatment.

Migraine affects 39 million people in the US, and more than 1 billion worldwide, according to the Migraine Research Foundation. People who have chronic migraine experience 15 or more migraine days a month. Those who have episodic migraine experience 14 or fewer headache days per month. In addition to headaches, a migraine attack can affect vision; cause dizziness and nausea; and lead to extreme sensitivity to light, sound, touch, and smells.

For decades, the primary treatment for acute migraine pain was a class of drugs called triptans. These drugs work by constricting blood vessels, so they aren’t recommended for people who have heart problems or high blood pressure. Side effects of triptans include neck or chest tightness and a rapid heart rate.
Lasmiditan, which comes in pill form, works in a different way. It targets and activates a receptor called 5-HT1F. It’s unclear exactly how the drug is treating migraine pain, but Lilly says that its therapeutic effects come from binding to this receptor. The receptor isn’t found on blood vessels, and tests have shown lasmiditan does not constrict blood vessels.

The FDA’s lasmiditan decision comes a little more than a year after Lilly won the regulatory nod for a different migraine drug, galcanezumab (Emgality). That drug blocks a protein associated with migraine pain called calcitonin gene-related peptide (CGRP). In addition to Lilly, Amgen (NASDAQ: AMGN) and Teva Pharmaceutical (NYSE: TEVA) were awarded FDA approval for their respective CGRP inhibitors. By blocking CGRP, these antibody drugs are intended to head off migraine pain before it starts. While they don’t stop all migraines, clinical trials showed that patients taking the drugs experienced a reduction in the frequency of their attacks. With lasmiditan’s approval, Lilly can now offer patients acute migraine treatment in addition to migraine prevention through galcanezumab.

Lasmiditan has taken a circuitous route to FDA approval. Originally discovered in Lilly’s labs, the compound was licensed to CoLucid Pharmaceuticals, a Durham, NC, startup founded in 2005. Ten years later, the biotech relocated to Cambridge, MA, and completed an IPO to finance late-stage tests of its migraine drug. In 2017, Lilly acquired CoLucid for $960 million, bringing lasmiditan full circle to finish Phase 3 studies, which enrolled more than 4,000 patients. Lilly filed for FDA approval of the drug last year.
The most common side effects reported from the lasmiditan studies included dizziness, fatigue, a burning or prickling sensation in the skin, and sleepiness. Lasmiditan can affect motor skills, so the FDA cautions against operating cars or machinery for at least eight hours after taking it.
Before lasmiditan becomes available in pharmacies, though, the Drug Enforcement Administration needs to determine how to classify the drug. Because lasmiditan affects the central nervous system, Lilly was required conduct additional studies to assess the risk that the drug could be abused: The tests showed less abuse risk compared to alprazolam, an anxiety disorders drug that comes with the risk of addiction. Lilly said it expects the DEA to issue its recommendation for how it should be classified within the next 90 days.