FDA Approves Fremanezumab, Behavioral Activation Therapy for MCI, Choosing DMTs for MS

September 22, 2018

Neurology News Network for the week of September 22, 2018.

This week, Neurology News Network covered the FDA approval of fremanezumab for the prevention of migraine, the success of behavioral activation therapy for black individuals with mild cognitive impairment, and Patricia Coyle's thoughts on the available disease-modifying therapies for multiple sclerosis. (Transcript below.)

Jenna:

Welcome to Neurology News Network. I’m Jenna Payesko.

Matt:

And I’m Matt Hoffman. Let’s get into the news from this week.

The FDA granted approval to fremanezumab, the second preventive therapy for migraine, joining erenumab in the CGRP inhibitor class. The approval for the Teva product was based on the supporting data from 2 studies in the phase III HALO clinical trial program. In the trials, the fully humanized anti-CGRP monoclonal antibody fremanezumab reduced monthly migraine days by ≥50% in roughly 45% of patients with episodic migraine and about 40% of patients with chronic migraine in clinical trials.

The wholesale cost for the monoclonal antibody will be $575 for the monthly dose and $1,725 for the quarterly dose, which is the same price announced for erenumab. Teva noted that out of pocket costs would vary based on insurance provider but could be as low as $0 per month for some patients.

Jenna:

When it comes to mild cognitive impairment, new study findings have suggested that behavioral activation is more beneficial for black individuals with mild cognitive impairment, or MCI.

Led by Barry W. Rovner, MD, from the Sidney Kimmel Medical College of Thomas Jefferson University, the study included 221 patients with amnestic MCI. They were randomized to receive either behavioral activation, which included goal setting and action plans to reinforce the practice of healthy activities, or supportive therapy. The incidence of 2-year memory decline was 1.2% for those receiving behavioral activation compared to 9.3% for those receiving supportive therapy, for a relative risk of 0.12.

Matt:

That’s good news, considering there aren’t any pharmacologic interventions available to patients with MCI. Unlike in multiple sclerosis, where the count on disease-modifying therapies numbers more than 15.

Jenna:

You know the saying, sometimes you can have too much of a good thing. The number of choices for physicians has led to a lot of trouble in deciding which DMT will be the most beneficial for patients with MS.

Matt:

Exactly. Although, according to the director of the Comprehensive Multiple Sclerosis Center at Stony Brook University, Dr. Patricia Coyle, it’s probably ok to emphasize the more efficacious therapies as good options.

Jenna:

Coyle said that while she doesn’t necessarily think one agent is heads and shoulders above the others, there are several factors that go into that decision-making process including administration, efficacy, and adverse effects.

Matt:

Those adverse effects have been the biggest obstacle for some therapies, according to Coyle. Although, when NeurologyLive sat down with her, she noted that there is an anti-CD20 antibody in development that could change that. Let’s take a look.

Jenna:

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