EisaiUS Tag

20 May

Posted at 16:43h in Alzheimer's - Dementia, Author Interviews, Cost of Health Care, JAMA, UCLA
MedicalResearch.com Interview with: [caption id="attachment_60418" align="alignleft" width="100"]Julia Cave ArbanasProject Manager and Julia Cave Arbanas[/caption] Julia Cave Arbanas Project Manager and     John N. Mafi, MD, MPH Associate Professor of Medicine General Internal Medicine & Health Services Research David Geffen School of Medicine at UCLAJohn N. Mafi, MD, MPH Associate Professor of Medicine General Internal Medicine & Health Services Research David Geffen School of Medicine at UCLA   MedicalResearch.com: What is the background for this study? What is lecanemab used for and how well does it work? Response: Lecanemab is a treatment for mild cognitive impairment and mild dementia that was approved in January 2023 as part of the Food and Drug Administration’s (FDA) accelerated approval program. The results from a recent phase 3 clinical trial show a modest clinical benefit: the rate of cognitive decline by 27% in an 18-month study involving participants experiencing the early stage of Alzheimer’s, with an 0.45-point absolute difference in cognitive testing scores. However, due to the risk of brain swelling and bleeding (also known as amyloid-related imaging abnormalities), treatment with lecanemab involves frequent MRIs and neurology or geriatrics appointments to monitor for these abnormalities, which can be life threatening. So far, three patient deaths have potentially been tied to lecanemab. It is likely that the FDA will grant is lecanemab traditional approval later this year, prompting Medicare to reconsider its current coverage restrictions and potentially enabling widespread use.

02 Oct

Posted at 20:20h in Author Interviews, Eisai, Insomnia
MedicalResearch.com Interview with: [caption id="attachment_52599" align="alignleft" width="125"]Margaret Moline, PhD Executive Director, Neurology Business Group, Eisai, Inc Lemborexant International Program Lead and Global Medical Lead Dr. Moline[/caption] Margaret Moline, PhD Executive Director, Neurology Business Group, Eisai, Inc Lemborexant International Program Lead and Global Medical Lead MedicalResearch.com: What is the background for this study? What are the main findings?
  • SUNRISE 2 was one of two pivotal Phase 3 studies evaluated in the U.S. Food and Drug Administration’s approval of DAYVIGO (lemborexant) CIV in December 2019.
  • SUNRISE 2 was a pivotal six-month placebo-controlled treatment trial with a 6-month active treatment period including adult patients age 18 or older who met DSM-5 criteria for insomnia disorder.
  • Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly for the first six months of the study (Treatment Period 1).
  • The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset).
  • Secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (sSE; the proportion of time spent asleep per time in bed) and subjective wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). These endpoints were measured by sleep diary.
  • At Virtual SLEEP 2020, a post-hoc analysis of SUNRISE 2 was shared in an oral presentation, which looked specifically at the long-term efficacy and safety of lemborexant in elderly adults with insomnia disorder.
  • Insomnia disorder, a chronic condition with long-term consequences for health and well-being, is prevalent in older adults.
  • This analysis of the SUNRISE 2 data reflects new learnings on the sustained impact of DAYVIGO on sleep onset and sleep maintenance in an older patient population. 

28 Dec

Posted at 13:49h in Author Interviews, JAMA, Sleep Disorders
MedicalResearch.com Interview with: [caption id="attachment_52595" align="alignleft" width="200"]Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc. Dr. Moline[/caption] Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc.  MedicalResearch.com: What is the background for this study? This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
  • On December 20, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) 5 mg and 10 mg, an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, which is characterized by difficulties with sleep onset and/or sleep maintenance.1
  • DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
  • SUNRISE 1 was a one-month, randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), lemborexant 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.1
  • The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring.1
  • The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG.1
  • SUNRISE 1, lemborexant 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. lemborexant 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.1
  • The effects of lemborexant at the beginning of treatment were generally consistent with later timepoints.