Galcanezumab Approved, Pimavanserin Safety Confirmed, Treating Augmentation in RLS, Genetics in Alzheimer

September 29, 2018

Neurology News Network for the week of September 28, 2018.

This week, Neurology News Network covered the FDA approval of galcanezumab for the prevention of migraine, as well the agency's confirmation of the safety of pimavanserin for Parkinson disease psychosis-related hallucinations and delusions. Also, advice from Mark Buchfuhrer, MD, about treating augmentation in restless legs syndrome, and an interview with Ron Crystal, MD, about the introduction of gene therapies into the treatment of Alzheimer disease. (Transcript below.)

Matt:

Welcome to Neurology News Network. I’m Matt Hoffman. Let’s get into the news from this week.

This week, the FDA approved the third member of the CGRP inhibitor class, with Eli Lilly’s galcanezumab joining erenumab and fremanezumab. The preventive migraine therapy is being marketed as Emgality.

It was assessed in a trio of phase III clinical trials—EVOLVE-1, EVOLVE-2, and REGAIN—all of which revealed a significant number of patients achieving a reduction of at least half of their monthly migraine days. Additionally, more than 10% of patients in both the 120-mg and 240-mg tested groups achieved a full, 100% reduction in monthly migraine days.

Dr. David Dodick, an investigator on several of the galcanezumab’s trials, told NeurologyLive that he is excited to know that there are patients that super-respond to these therapies. “We may see these people for whom there’s just been a dramatic change in the expression of this disease because of the pivotal role that CGRP plays in the biology of their illness,” he said.

This week, the FDA also reiterated safety information about pimavanserin, marketed as Nuplazid, for the treatment of hallucinations and delusions due to Parkinson disease psychosis.

Since the therapy was approved for this indication in April 2016, the agency reviewed all available data from postmarketing reports of deaths and serious adverse events (SAEs) reported with the use of the drug. “After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis,” the agency concluded.

The FDA stated that overall, the data were consistent with the safety data included in the controlled clinical trials of pimavanserin for Parkinson disease psychosis which were submitted with the NDA. This data comprised of 25 clinical studies, including of a phase 3 trial, all of which totaled more than 1200 patients.

For clinicians treating restless leg syndrome, the issue of augmentation has become a hot topic in recent years. To find out why, NeurologyLive spoke with Dr. Mark Buchfuhrer, a national RLS expert, about the condition. He acknowledged that 75% or more of his referrals are patients with severe augmentation, which can be best treated by opioids—though with an epidemic ongoing, this not always a welcome option. Many augmentation cases, he said, are worsened by a lack of understanding of how to treat the condition.

Buchfuhrer said that in order to prevent things from worsening, he suggests avoiding the short-acting dopamine agonists, such as Mirapex and Requip, in higher doses. Instead, he recommended either splitting the FDA approved 0.5-mg dose, giving one half earlier and one half later, or simply giving the full dose at an earlier time. Other options, he noted, included adding gabapentin or pregabalin, or switching to a long-acting dopamine agonist.

This week, NeurologyLive sat with Ronald Crystal, MD, the chairman of the Department of Genetic Medicine at Weill Cornell Medicine, about the introduction of gene therapies for the treatment of Alzheimer disease. Crystal specifically spoke about a strategy to correct the risk of Alzheimer by adding E2 to the APOE4 gene. Let’s take a look.

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.