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MS therapeutics: 1 withdrawal, 1 setback

…ical pharmacology sections of the application were insufficient to allow a complete review. Celgene will meet with FDA officials to discuss what additional information is needed, but the setback is expected to significantly delay the launch of ozanimod. The drug was expected to obtain approval in late 2018/early 2019, but that will likely be delayed at least 9-12 months. As a result, ozanimod is now expected to be launched in the U.S. after generi…

DMF: the Canadian MS patient experience

…and resources to MS patients, and attracts about 35,000 visitors per year (www.msology.com). The 21-item survey asked patients currently treated with DMF about their experiences with the drug. All of the Canadian respondents (n=48) were current or recent DMF users. A majority of respondents were female (96%), aged 41 years or older (81%). Forty-percent were previously untreated, and 60% had been on a prior injectable DMT. Most had been taking DMF…

Third failed trial for solanezumab in AD

…and cognition, which partially offset the adverse effects of longer forms (e.g. Aβ42). Thus, indiscriminately reducing all beta-amyloid forms may worsen cognition in patients with a low baseline beta-amyloid load (Geerts et al. Alzheimers Res Ther 2018;10:14; free full text at www.ncbi.nlm.nih.gov/pmc/articles/PMC5797372/pdf/13195_2018_Article_343.pdf). As such, the authors offer the counterintuitive suggestion that amyloid-lowering agents may ac…

ECTRIMS/EAN publish new MS treatment guidelines

…018; epublished January 1, 2018; free full text at http://journals.sagepub.com/doi/pdf/10.1177/1352458517751049). The groups identified 10 key questions, and issued a series of recommendations based on the level of evidence. The following is a summary of the groups’ recommendations. Therapeutic intervention 1- All DMDs should be prescribed only in centres with adequate infrastructure to provide proper patient monitoring, comprehensive assessment,…

2017 U.S. drug approvals in neurology and psychiatry

…2017;174:476-484). A separate phase II trial in Tourette’s syndrome was unsuccessful, but a new study is planned using a higher dose. Cerlipnase alfa (Brineura, BioMarin): this agent, a recombinant human tripeptidyl peptidase-1 (TPP1), was approved to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2), a rare inherited neurodegenerative disease caused by a deficiency in TPP1. The drug will be one o…