Ocrelizumab Compared to Other DMTs, Effects of Lemborexant on Next-Day Driving, BHV-3241 Gets FDA OK for Clinical Trial
Neurology News Network for the week of January 26, 2019.
PUBLISHED January 26, 2019
This week, Neurology News Network covered the findings of a systematic review of the efficacy and safety of the available disease-modifying therapies in multiple sclerosis, the results of a phase 1 exploration of lemborexant's impact on next-day driving in adult patients, and the FDA May Proceed Letter received by Biohaven Pharmaceuticals regarding its novel myeloperoxidase inhibitor, BHV-3241. Additionally, the network covered a conversation with Joseph Sullivan, MD, about defining a clinically meaningful change in seizure frequency for patients with epilepsy. (Transcript below.)
Welcome to Neurology News Network. I’m Jenna Payesko.
And I’m Matt Hoffman. Let’s get into the news from this week.
Using a number of network meta-analyses, a systematic review has shown that ocrelizumab is superior, or at least comparable, to more than 10 currently available disease-modifying therapies for relapsing multiple sclerosis.As well, the safety profile of the humanized anti-CD20 monoclonal antibody was found to be similar to each of the DMTs included in the analysis.
Investigators wrote that the findings support that ocrelizumab “offers a complete and valuable package for the treatment of patients with RMS.” They ranked the treatments by using surface under the cumulative ranking curve values, finding that 600-mg ocrelizumab ranked in the top 3 for annualized relapse rate, 12-week confirmed disease progression, and serious adverse events. For discontinuation for due to adverse events, it ranked seventh.
The results of a phase 1 safety study recently published in SLEEP determined when evaluating the impact of bedtime administration of lemborexant, a therapy under investigation for treatment of insomnia, there were no statistically significant or clinically relevant effects on next-morning driving performance in adult and elderly healthy volunteers compared to placebo.
Study 106, which evaluated the next-morning effects of lemborexant 2.5 mg, 5 mg, and 10 mg doses compared to placebo, was designed to evaluate the effect of lemborexant on driving performance after single and repeated bedtime use in healthy adult and elderly volunteers 23 to 78 years of age.
Biohaven received the agency’s May Proceed Letter following the reactivation of AstraZeneca’s original Investigational New Drug application once it acquired the licensing for the treatment in September 2018. It was previously known as AZD3241.
In a conversation with NeurologyLive, Dr. Joseph Sullivan, the director of the Pediatric Epilepsy Center at UCSF Benioff Children's Hospital spoke about what defines a clinically meaningful change in seizure frequency using data from a phase 3 clinical trial of ZX008 for the adjunctive treatment of seizures associated with Dravet syndrome.
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.