Daridorexant Improves Daytime Sleepiness, Vutrisiran Gains Fast Track Designation, Erenumab Effective in Migraine

The week Neurology News Network covered top-line results from the insomnia drug daridorexant, as well as the fast track designation of vutrisiran, and the interim analysis of erenumab which was slated to be presented at the American Academy of Neurology (AAN) 2020 Annual Meeting.

Marco Meglio: 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

Top-line results from a study of daridorexant in adults with insomnia demonstrate the agent’s efficacy on objective and subjective sleep parameters, as well as daytime performance with no residual effect in the morning and no evidence of rebound or withdrawal symptoms upon treatment discontinuation, according to Idorsia, the developer of the dual orexin receptor antagonist. Doses of both 25 mg and 50 mg daridorexant significantly improved sleep onset and sleep maintenance as measured objectively in a sleep lab by polysomnography. Self-reported data from daily diaries showed the drug’s significant impact on subjective total sleep time, as well. Guy Braunstein, head of Global Clinical Development at Idorsia said in a statement, “The results from this pivotal study are truly remarkable for the consistency of the benefit in sleep measures. Moreover, this is the first study to demonstrate an insomnia product can improve how the patient feels during the day. If you ask anybody who suffers from insomnia that is what they want—to sleep longer and feel better during day. Daridorexant is addressing real patient problems.”

Alnylam Pharmaceuticals has announced that the FDA has granted its drug vutrisiran fast track designation for the treatment of polyneuropathy associated with hATTR amyloidosis in adults. The investigational agent, which is delivered via subcutaneous injection, is destined to be part of a 1-2 punch alongside Alnylam’s currently approved therapy patisiran, which is approved for the same indication but delivered via intravenous infusion. Vutrisiran is also being evaluated against placebo in the ongoing HELIOS-B phase 3 clinical trial in patients with ATTR amyloidosis with cardiomyopathy. The composite primary outcome of that trial, which has a target enrollment of 600 participants, is all-cause mortality and recurrent cardiovascular hospitalizations at 30 months. Alnylam plans to readout topline results from HELIOS-A sometime early next year.

Interim analysis of erenumab from the TELESCOPE study confirmed the monoclonal antibody’s real-world and long-term safety and benefit in patients with episodic and chronic migraine. Data included 109 patients from Germany, and showed an average reduction of 8 migraine days with erenumab therapy. Additionally, 80% of the patients felt a reduction of intensity and 92% of patients had a reduction of frequency of their attacks. Using global impression scores, treating physicians noted 80% of the patients were rated as “much improved” or “very much improved” after receiving erenumab. These data from TELESCOPE were accepted to the American Academy of Neurology (AAN) 2020 Annual Meeting. Erenumab, the first-in-class fully human monoclonal antibody against CGRP was approved by the FDA in May 2018 for the prevention of migraine after it showed significant improvement in 3 different clinical trial.

Although AAN has been canceled, the coverage for slated presentations continues. Head to NeurologyLive.com for more direct access to expert insight, as well as the top news from what would have been presented at AAN. This has been Neurology News Network. Thanks for watching.