MS News That Caught My Eye Last Week: Ublituximab, Lyvispah, Diet Study

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by Ed Tobias |

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FDA Decision on Ublituximab for Relapsing MS Pushed to Year’s End

Ublituximab is similar to Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), which also target B-cells, the immune cells that play a role in the inflammatory attacks that harm the central nervous system of people with MS. Each of these treatments also had a review by the U.S. Food and Drug Administration extended prior to final approval. Ublituximab, like Ocrevus, is a twice-yearly infusion. Kesimpta is a monthly injection.

The U.S. Food and Drug Administration (FDA) is extending by three months its review of ublituximab, an experimental anti-CD20 antibody being developed by TG Therapeutics for relapsing forms of multiple sclerosis (MS).

The FDA had agreed to review the company’s application requesting ublituximab’s approval late last year, and initially planned to announce its decision by late September. That decision is now expected on Dec. 28.

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Lyvispah, Dissolvable Form of Baclofen, Now Available in US

Swallowing difficulties are estimated to affect 34–43% of people with MS. The release of a form of baclofen that need not be swallowed should be good news for them. Lyvispah can be taken with or without water, mixed with liquids or foods, or administered through an enteral feeding tube. The medication will be available via retail and specialty pharmacies.

Lyvispah — a dissolvable granular formulation of baclofen — is now commercially available in the U.S. for adults and adolescents, 12 and older, with spasticity associated with multiple sclerosis (MS) and other spinal cord disorders.

In people with MS, the strawberry-flavored formulation is particularly suitable to ease flexor spasticity and associated pain, muscular rigidity, and repetitive, involuntary up and down muscle movements. Flexor spasticity is the involuntary bending of the knees and hips toward the chest, which can be painful and incapacitating.

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$3.9M Grant Awarded to Study Effects of Low-glycemic Diet

Have you been using a particular diet to help treat your MS? There are several in common use, although the National Multiple Sclerosis Society says there is no specific “MS diet.” The researchers in this study will be looking at whether eating more green vegetables, fruits, beans, and nuts — foods that can lower blood sugar spikes — can help. The researchers will also study whether losing excess weight is a necessary component to improving MS outcomes.

The U.S. Department of Defense (DOD) has awarded $3.9 million to fund clinical research to test the impact of a low-glycemic diet on physical, cognitive, and psychological function in people with multiple sclerosis.

The four-year project, called “Impact of diet quality and calorie restriction on physical function and patient-reported outcomes in multiple sclerosis,” will take the form of a clinical trial (NCT05327322) that’s expected to launch in November.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

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