From Multiple Sclerosis News Today, March 24, 2016:
Potential Progressive MS Treatment, Ibudilast, Approved for Fast Track Development by FDA
Carolina Henriques
MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease.
MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential in treating relapsing-remitting MS (RRMS). MN-166 is a first-in-class, orally bioavailable, small-molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that works by suppressing pro-inflammatory cytokines and promoting neurotrophic factors. It reduces activated glial cells, which play a significant role in a number of neurological conditions.
Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, that were the basis for investigating its ... utility in neurodegenerative diseases like progressive MS and amyotrophic lateral sclerosis, and in substance abuse and chronic neuropathic pain.
“We are very pleased that MN-166 has received Fast Track Designation for progressive MS and believe this validates its potential to address unmet medical needs for this serious disease. We look forward to providing further updates from our ongoing clinical trial in progressive MS,” Yuichi Iwaki, MD, PhD, MediciNova’s president and chief executive officer, said in a press release.
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Current MS therapies address the inflammatory response in RRMS, but are of limited or no benefit regarding neurodegeneration or brain tissue repair.
The FDA’s Fast Track designation is awarded to speed the development and review of drugs with the potential to address unmet medical needs in serious or life-threatening diseases.