Welcome to the latest edition of Neuroscience Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
Roche has announced promising results from the Phase III FENtrepid study, showing that fenebrutinib significantly reduced disability progression by 12% in patients with primary progressive multiple sclerosis, or PPMS. This data positions fenebrutinib as a potential first-in-class oral Bruton’s tyrosine kinase (BTK) inhibitor for both PPMS and relapsing MS. Additionally, the study revealed favorable outcomes for upper limb function, further supporting fenebrutinib’s potential to change the treatment landscape for these patients.
In Canada, Teva’s PrAJOVY® (fremanezumab) has received approval from Health Canada for the prevention of episodic migraine in pediatric patients aged 6 to 17. This makes PrAJOVY® the first CGRP antagonist approved for pediatric use, expanding treatment options for children and teens who suffer from frequent migraines. With its new indication, PrAJOVY® offers a significant advance in addressing the needs of young patients with this debilitating condition.
Kite, a Gilead company, has received an FDA label update for Yescarta®, allowing it to be used for relapsed or refractory primary central nervous system lymphoma (PCNSL) without prior limitations. This updated label highlights Yescarta’s safety and efficacy for treating this aggressive form of lymphoma, making it a more accessible treatment option for patients who previously had limited choices for their condition.
Eisai and Biogen’s subcutaneous formulation of LEQEMBI® (lecanemab) for Alzheimer’s disease has been granted priority review by China’s National Medical Products Administration (NMPA). If approved, this formulation will provide a convenient, home-administered, weekly dosing alternative to traditional intravenous treatments, helping alleviate the burden on healthcare resources and offering a more accessible treatment option for patients with Alzheimer’s disease.
The European Commission has approved Amgen’s UPLIZNA® (inebilizumab) as an add-on therapy for generalized myasthenia gravis (gMG). UPLIZNA® offers a twice-yearly dosing schedule, potentially reducing the need for long-term steroid use in patients with gMG. This approval marks a significant milestone in improving long-term treatment options for gMG patients and reducing steroid dependency.
Lundbeck has announced positive Phase IIb results for bocunebart, an anti-PACAP antibody developed for migraine prevention. In the PROCEED trial, bocunebart met its primary endpoint, showing effectiveness in patients who had previously failed other treatments. These results offer new hope for patients with severe, treatment-resistant migraine, providing them with a potential new therapy option.
Denovo Biopharma has partnered with Orygen to launch a Phase 2 study of DB103 (pomaglumetad methionil) in the treatment of first-episode psychosis. The study will focus on evaluating the effects of DB103 in patients with psychosis and those at clinical high risk for psychosis. If successful, DB103 could offer a novel treatment option for young patients experiencing psychosis, a critical time for intervention.
Finally, Alto Neuroscience has completed enrollment in its Phase 2 study of ALTO-101, which is investigating its potential to address cognitive impairment in schizophrenia. The study will assess ALTO-101’s effects on brain-based EEG measures. Cognitive impairment remains a major challenge for schizophrenia patients, and ALTO-101 could represent a breakthrough in managing this debilitating aspect of the disease.
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