- Eli Lilly on Friday won Food and Drug Administration approval for a migraine drug it acquired via a 2017 deal for CoLucid Pharmaceuticals, giving the Indianapolis pharma a partner treatment to its on-market therapy Emgality.
- Reyvow, as Lilly's drug will be sold, is approved to treat migraines as they develop, rather than to prevent the debilitating headaches from emerging in the first place, as Emgality is cleared to do.
- The FDA's OK of Reyvow adds to a stretch of drug development activity that's now resulted in four new treatments becoming available since last spring. Emgality, along with Novartis and Amgen's Aimovig and Teva's Ajovy, all belong to a class of preventive therapies known as CGRP inhibitors, while Reyvow works via a different biological mechanism.
Approval of Reyvow completes a circuitous development journey for a drug previously known as lasmiditan.
Lilly licensed the then-experimental compound to CoLucid in 2005. Twelve years later, after the success of a Phase 3 study called SAMURAI, Lilly bought the company for $960 million and brought lasmiditan back into its pipeline.
Now, Reyvow will be part of Lilly's efforts to build a therapeutic franchise in migraine, a condition estimated to affect as many as one in seven Americans.
The pharma was third to market with its preventive offering Emgality (galcanezumab), following approvals of first Aimovig (erenumab) and then Ajovy (fremanezumab).
Competitive jockeying for market share led all three companies to offer lengthy free drug programs following their respective launches — creating a showdown that's seen Amgen and Novartis retain an advantage in prescription numbers.
Reyvow differs from those three drugs in several ways. It's designed to be used as an acute treatment, works by binding to serotonin (5-HT)1F receptors rather than calictonin gene-related peptides (CGRP) and is administered via tablet rather than injection.
Testing in SAMURAI and another study called SPARTAN showed Reyvow resolved pain and lessened migraine symptoms like nausea or light sensitivity in more patients than placebo after two hours.
The FDA approved Reyvow to treat migraine that presents with or without aura, the flashing lights or visual field phenomena that can sometimes accompany migraine attacks.
Reyvow comes with a warning, however, of a risk of driving impairment. People taking the drug are advised not to drive or operate machinery for at least eight hours after taking Reyvow — a stipulation that could give some migraine sufferers pause before turning to the drug.
Reyvow can also cause dizziness and sedation. As it's active in the central nervous system, Lilly studied the drug for abuse potential and found it to be associated with less drug liking than the sedative alprazolam, but more than placebo.
The Drug Enforcement Administration is currently reviewing Reyvow for controlled substance classification, a typically 90-day process after which the treatment will be available in retail pharmacies.
Lilly did not disclose a price at approval, saying cost information would be released nearer to market launch.
Other companies, including BioHaven Pharmaceuticals and Allergan, are also advancing migraine therapies toward FDA review. Another potential entrant is Alder BioPharmaceuticals, which was acquired last month by Danish drugmaker Lundbeck for $1.95 billion.