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Temelimab for Multiple Sclerosis

Last updated June 9, 2022, by Lindsey Shapiro, PhD

Fact-checked by Ines Martins, PhD

FAQs about temelimab in MS

Temelimab is an experimental antibody therapy that is not yet approved for the treatment of multiple sclerosis (MS). It is designed to block the effects of a viral protein, pHERV-W, which is known to contribute to the damaging immune response in MS. Clinical trials in relapsing forms of the disease have shown a slower brain tissue loss and preserved myelin after temelimab treatment.

It is still too early to know if or when the medication might be approved by the U.S. Food and Drug Administration. Temelimab has shown promising neuroprotective effects in Phase 2 trials involving people with relapsing forms of multiple sclerosis. But an optimal dose for future clinical trials has not yet been determined, and additional studies will be needed before any application for approval can be submitted.

Clinical trials of temelimab have not included people who were pregnant or breastfeeding, and all who had the ability to reproduce were required to use effective methods of contraception. It is not known whether the therapy is safe for such patients.

In the CHANGE-MS clinical trial, a 18 mg/kg dose of temelimab resulted in significant reductions in brain volume loss and in preserved myelin integrity after one year of treatment. However, multiple sclerosis manifests differently in all patients and responses to treatment may vary.

Hair loss and weight gain were not reported as side effects of temelimab in multiple sclerosis clinical trials. Patients who experience unexpected side effects after starting any new treatment are advised to speak with their healthcare providers.

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.

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