Neurology News Network for the week ending October 19, 2019.
This week, Neurology News Network covered the FDA approval of lasmiditan, the first agent in the ditan class approved for the treatment of acute migraine in adults, market availability of Kyowa Kirin's istradefylline (Nourianz) for Parkinson disease off episodes, and top-line results from Reata Pharmaceutical's phase 2 MOXIe trial of omaveloxolone for the treatment of Friedreich's ataxia.
Alicia: Welcome to Neurology News Network. I’m Alicia Bigica. Let’s get into the news from this week.
The FDA has approved Eli Lilly’s lasmiditan for the acute treatment of migraine with or without aura in adults. The drug, an oral, centrally-penetrant, selective serotonin 5-HT1F agonist, is the first molecule in the ditan class to be approved for migraine. The regulatory decision was based on findings from 2 phase 3 trials, SAMURAI and SPARTAN, which suggested that treatment with lasmiditan, which will be marketed as Reyvow, is associated with a high rate of pain-freedom from migraine as well as freedom from most bothersome symptom. In those trials, some patients reported experiencing dizziness, fatigue, nausea, parathesia, and somnolence. Despite the drug’s association with sedation, it will likely play a role for patients who do not respond to treatment with gepants or who have cardiovascular risk factors in which triptans are contraindicated.
Less than 2 months after its FDA approval, istradefylline is now available in the United States as adjunctive treatment to levodopa/carbidopa for patients with Parkinson disease who experience off episodes. The drug, which is marketed as Nourianz, was approved by the FDA in late August based on results from 4 clinical studies that included more than 1100 participants. The oral selective adenosine A2A receptor antagonist demonstrated statistically significant decreases from baseline in daily off time compared with placebo. The most common adverse effects seen with treatment were dyskinesia, dizziness, constipation, nausea, hallucinations, and insomnia. To help offset drug costs and access issues, Kyowa Kirin has launched the Kyowa Kirin Cares program, which will provide access and reimbursement support for patients and caregivers.
Top-line results from Reata Pharmaceutical’s phase 2 MOXIe trial in patients with Friedreich’s ataxia showed a 2.4-point improvement in the Friedreich’s Ataxia Rating Scale (mFARS) score in patients treated with omaveloxolone compared with placebo. The 2-part study, which is the largest global interventional trial ever conducted in the disease, is a randomized, placebo-controlled, double-blind study conducted over 48 weeks, in which patients are randomly assigned to either 150 mg of omaveloxolone or placebo. Those who were treated with the study drug experienced a statistically significant improvement in mFARS score. Given the results, Reata plans to proceed with regulatory submissions.
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