FDA approves MS drug for human trials

pharmafile | January 27, 2020 | News story | Sales and Marketing MS, MS symptoms, MS treatment, Neuro, neurology 

A drug that can make it easier to diagnose Multiple Sclerosis (MS) has been approved for its first human trials by the FDA.

The drug is called Myeliviz and it targets and binds to myelin, the sheathing surrounding nerves that are affected by MS, and allows for its imaging by a PET scanner. This will potentially provide a new source of evidence to assess the extent of the damage to the nervous system from MS. It also may be able to replace MRI scans of the brain and spine, which are generally seen as a less effective way of monitoring the disease.

MS can damage the Central Nervous System before symptoms become apparent. The potential offered by Myeliviz means more cases could be diagnosed earlier and current treatments could help treat the severity of the debilitating impacts from MS.

Chunying Wu, the drug’s co-inventor and instructor of radiology at Case Western Reserve, said: “Myeliviz could be the missing link in finding a cure for MS and other myelin diseases by serving as a specific and quantitative imaging marker for early diagnosis and sensitive, quantitative evaluation of novel therapies currently under development.”

The upcoming trials have been made possible due to a $1.7 million grant from the National Institutes of Health. They will be conducted on healthy volunteers at the Cleveland Clinic Mellen Center for Multiple Sclerosis.

The study could reveal wider conditions Myeliviz could treat. Mykol Larvie, Director of functional neuroimaging at Cleveland Clinic, who led efforts on the FDA application process, said: “This drug may provide improved ongoing monitoring of brain health in general—and help doctors more accurately gauge the effectiveness of treatments in numerous neurological diseases such as epilepsy, stroke, neurodegeneration, tumour and trauma in the brain and spinal cord.”

Conor Kavanagh

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