New migraine drugs have recently obtained approvals for local clinical trials, raising the chance that they will enter the domestic market.
Primary migraine treatments in development include Lilly’s galcanezumab (under the clinical trial name of LY2951742), Novartis’ erenumab (AMG334), and Teva’s crenezumab (TEV-48125).
The drugmakers of the three drug candidates either have conducted local clinical trials or plan for a clinical trial. Fremanezumab obtained the latest approval for a clinical trial plan.
The investigational drug was approved by the Ministry of Food and Drug Safety for a phase-2b/3 clinical trial to prevent and treat a chronic migraine (CM) on Dec. 13. Then, it also won approval for a phase-3a trial to prevent and treat a headache and for a phase-2b/3 clinical trial to prevent and treat an episodic migraine (EM) on Dec. 18.
Novartis Korea also received approval for a local clinical trial of erenumab. The MFDS on Dec. 12 approved a phase-3 clinical trial, which is to test the efficacy and safety of the drug’s once-monthly injection on adult patients with interval EM, compared to placebo takers, for 12 weeks.
Lilly Korea won approval for galcanezumab’s local phase 3 clinical trial in December 2015 to test the efficacy and safety of the drug on interval migraine patients. Galcanezumab is at a faster development stage than other drug candidates. On Dec. 11, the U.S. FDA accepted Lilly’s biologic license application (BLA) to review galcanezumab. The drug in development can be injected beneath the skin, once a month.
Fremanezumab, erenumab, and galcanezumab all target calcitonin gene-related peptide (CGRP), being developed in injections beneath the skin.
Other investigational migraine treatments include CoLucid Pharmaceuticals’ lasmiditan, for which Ildong Pharmaceutical has a sales license, although it was not tested in a local clinical trial. As a migraine treatment, Lasmiditan selectively works on 50HT1F receptor only, through a ditan-related mechanism, and directly targets the trigeminal nerve system.
The experimental drug was reportedly effective for patients who did not respond to existing triptane-related drugs. It also reduced side effects on the cardiovascular system with blood vessel contractions, often shown by existing migraine treatments.
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