FDA Approves Epidiolex For TSC, Atogepant Reduces Monthly Migraine Days, Lancet Publishes Updated Dementia Risk Factors

August 8, 2020

Neurology News Network for the week ending August 8, 2020.

This week Neurology News Network covered the new FDA expanded indication for cannabidiol in pediatrics with tuberous sclerosis complex, positive phase 3 results of atogepant for patients with episodic migraine, and an updated Lancet Commission report that focuses on 12 risk factors that reduce dementia incidence.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

The FDA has approved a new indication for cannabidiol for the treatment of seizures associated with tuberous sclerosis complex, a rare disease that is the leading cause of genetic epilepsy. The oral solution is approved for use in patients age 1 and older with TSC. Notably, the FDA also expanded the approved age range to patient age 1 and older for the treatment’s other indications, including treatment of Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex was first approved in June 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, 2 rare, treatment refractory types of epilepsy in patients aged 2 and older. The updated indication now makes the treatment available to these patients who are age 1 and older. Additionally, the FDA’s recommended maintenance dose in patients with TSC is 25 mg/kg/day.

AbbVie recently announced positive results from the phase 3 ADVANCE clinical trial of atogepant in those with episodic migraine, with the agent reporting statistically significant improvements in monthly migraine days compared with placebo. The small molecule calcitonin gene-related peptide receptor antagonist, or gepant, met the primary end point, with those treated in the 10-, 30-, and 60-mg arms experiencing decreases in MMD of 3.69, 3.86, and 4.2 days, respectively, compared with 2.48 days with placebo over the 12-week treatment period. ADVANCE included 910 patients, with the efficacy analyses based on the modified intent-to-treat population of 873 patients. Thomas J. Hudson, senior vice president, research and development, and chief scientific officer, AbbVie, said in a statement, “With the results from these trials, we aim to provide a safe and effective preventive treatment that offers patients and healthcare providers a simple, once daily oral treatment that works specifically by blocking CGRP receptors and preventing migraine.”

An update to the Lancet Commission report on dementia prevention, intervention, and care published by 28 world-leading dementia experts and presented at the 2020 Alzheimer's Association International Conference annual meeting, outlines 12 potentially modifiable risk factors to prevent or delay up to 40% of cases of dementia. The authors found that 9 potentially modifiable risk factors for people in low income and middle income countries together are associated with 35% of the population attributable fraction of dementia worldwide. Among them are less education, high blood pressure, obesity, hearing loss, depression, diabetes, physical inactivity, smoking, and social isolation, assuming causation. The current report, which is an update to the 2017 Lancet Commission, also now includes 3 new risk factors: excessive alcohol intake, head injury, and air pollution.

For more direct access to expert insight and coverage of this year’s AAIC annual meeting, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.