Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache
INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults.
Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity. It is the first and only molecule in the "-ditan" class under evaluation for the acute treatment of migraine in adults. If approved, it could represent the first significant innovation for the acute treatment of migraine in more than two decades.
Lilly also plans to submit an sBLA to the FDA for Emgality for the preventive treatment of episodic cluster headache in adults by the end of the year. The FDA has granted Breakthrough Therapy Designation to Emgality for episodic cluster headache. Breakthrough Therapy Designation is a process that is intended to expedite the development and review of drugs that treat serious or life-threatening diseases and, based on preliminary clinical evidence, may demonstrate substantial improvement over available therapies. Currently, there are no approved preventive treatments for episodic cluster headache in the U.S.
"Headache disorders like migraine and cluster headache affect each person differently, and many patients spend years cycling through different medications to effectively diagnose and treat their symptoms," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines. "Lilly has spent the last 25 years researching innovative therapies to treat headache disorders, and we are thrilled to be one step closer to potentially providing new and different options with lasmiditan for the acute treatment of migraine and Emgality for the preventive treatment of episodic cluster headache."
The NDA for lasmiditan includes data from two Phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of lasmiditan for the acute treatment of migraine. In both studies, at two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was significantly greater compared to placebo. These results were significant across all studied doses. Lasmiditan also met the key secondary endpoint, with a significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose. In these studies, patients chose their MBS from sensitivity to light, sensitivity to sound or nausea. The most commonly reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness and numbness. Data from these studies were presented at the American Headache Society (AHS) annual meeting and the American Academy of Neurology (AAN) annual meeting.
"As a caregiver for someone living with chronic migraine, I know firsthand how disabling headache diseases can be," said Kevin Lenaburg, executive director of the Coalition For Headache And Migraine Patients (CHAMP). "We're excited about the new innovations in the acute treatment of migraine and the preventive treatment of migraine and episodic cluster headache, and we're thankful for Lilly's commitment to continue to investigate and hopefully bring these important new therapeutic options to market."
Lasmiditan and Emgality represent two of three treatments in Lilly's pain portfolio. Emgality was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The portfolio also includes tanezumab, developed in partnership with Pfizer, which is currently being investigated for the treatment of osteoarthritis pain, chronic low back pain and cancer pain.
Indications and Usage for Emgality
Important Safety Information for Emgality
GZ HCP ISI 27SEP2018
About Cluster Headache
About Lilly's Commitment to Headache Disorders
About Eli Lilly and Company
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Emgality (galcanezumab-gnlm) as a treatment for patients with migraine and as a potential treatment for patients with episodic cluster headaches; lasmiditan as a potential treatment for patients with migraine; and tanezumab as a potential treatment for patients with osteoarthritis, chronic low back pain and cancer pain and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Emgality, lasmiditan or tanezumab will receive additional regulatory approvals. There can also be no guarantee that any of these molecules will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 Katsarava Z, Buse D, Manack A, et al. Defining the differences between episodic migraine and chronic migraine. Current Pain Headache Reports. 2012;16:86.
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