Siponimod NDA Accepted, New Appropriate Use Criteria for Alzheimer Disease Diagnosis, Disease-Modifying Therapy


Neurology News Network for the week of Oct. 12, 2018.


Welcome to Neurology News Network. I’m Jenna Payesko. Let’s get into the news from this week.

This week, Novartis announced the FDA acceptance of a new drug application for siponimod, an oral, once-daily medication under investigation for treatment of secondary progressive multiple sclerosis in adults. The acceptance is backed by data from the phase III EXPAND study which demonstrated that siponimod consistently resulted in disability progression in the intended patient population.

Bruce Cree, EXPAND study steering committee member and clinical research director and associate professor at the University of California, San Francisco, School of Medicine, told MD Mag, NeurologyLive’s sister publication, that a gap in treatment exists for the inflammatory-neurological duality of SPMS—a gap that siponimod has shown its ability to fill. “Siponimod's beneficial effect on preventing disability progression, independent from its reduction in relapse frequency, demonstrates that patients with secondary progressive MS could benefit from this treatment,” Cree concluded.

Earlier this week, the Alzheimer’s Association published new appropriate use criteria guiding safe use of lumbar puncture and spinal fluid analysis for Alzheimer disease pathology detection in the diagnostic process, finalizing 14 indications, and rating 6 appropriate and 8 inappropriate. The discussion of the appropriateness or inappropriateness of these indications is intended to aid dementia experts in making decisions regarding tests and help primary care and other clinicians in determining when to refer to a dementia expert for specialized testing. The workgroup emphasizes that while CSF testing can provide important information, it is not a substitute for a careful history and clinical examination.

NeurologyLive spoke with Dr. James Hendrix, director of global science initiatives at the Alzheimer’s Association, to discuss the clinical impact of this criteria: “Clinicians should understand that this is not a screening test or a first line test, this is something that really should be done by a dementia expert or a neurologist or gerontologist, somebody who has a pretty strong knowledge of Alzheimer and dementia and can diagnose and interrupt the results when they come,” he said. “It could be that a primary care physician has a patient they are trying to diagnose or trying to obtain a more precise diagnosis, but they’re going to have to refer them to a specialist and the specialist would then determine if a CSF test is appropriate for that type of patient.”

This week at ECTRIMS 2018, NeurologyLive sat down with John Corboy, MD, professor of neurology at the University of Colorado, to discuss one topic not often discussed—taking patients off of disease-modifying therapy. Let’s take a look.

For more direct access to expert insight, head to This has been Neurology News Network. Thanks for watching.

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