Lecanemab Adds Quality-Adjusted Life Years, FDA to Hold AdComm Meeting Over NurOwn, SYMBYX Neuro Improves PD Symptoms

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Neurology News Network for the week ending April 1, 2023. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Recently published data using an evidence-based model developed to simulate the effects of lecanemab suggested that lecanemab plus standard of care (SoC) would improve health and humanistic outcomes and reduce economic burden for patients and caregivers in early Alzheimer disease (AD). Over a lifetime time horizon, patients treated with lecanemab plus SoC gained an additional 0.62 years of life vs SoC alone (6.23 years vs 5.61 years). The mean time on lecanemab was 3.91 years, and the treatment was associated with an increase in patient quality-adjusted life years (QALYs) of 0.64 when both patient and caregiver utilities were considered. When excluding drug acquisition costs, the total costs per patient on a combination of these therapeutic approaches decreased by $6263 from a payer perspective and $7451 from a societal perspective relative to SoC alone.

After months of discussion with the FDA, BrainStorm Cell Therapeutics has announced the agency will hold an advisory committee meeting hearing to discuss the company’s investigational stromal cell therapy, a potential treatment for patients with amyotrophic lateral sclerosis (ALS). To expedite this process, BrainStorm requested that the Center for Biologics Evaluation and Research (CBER) utilize the FDA’s File Over Protest procedure. In November 2022, BrainStorm received a refusal to file letter from the FDA for the biologics license application (BLA) of NurOwn; however, the company has now filed an amendment to the BLA that responded to most of the outstanding questions the FDA had posed. NurOwn, or autologous mesenchymal stromal cells secreting neurotrophic factors cells (MSC-NTF), had its BLA based on a phase 3 study in which the agent originally failed to meet its primary end point, but continued to significant effects on less severe forms of ALS.

Newly announced findings from a triple-blinded, randomized controlled trial showed that treatment with SYMBYX Neuro infrared light therapy helmet significantly improved symptoms of Parkinson disease (PD) in areas of facial expression, upper and lower limb coordination and movement, walking gait, and tremor. Currently under review by a peer reviewed journal, study responders demonstrated moderate to strong positive response to treatment over a 12-week period. Using the standardized Movement Disorder Society Unified Parkinson’s Disease Rating Scale-III (UPDRS-III), compared with the placebo group, those on the light therapy improved 24% to 58% over baseline across all 5 areas tested, unlike the placebo group, which demonstrated statistically valid improvement in lower limb coordination and movement only.

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