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January 18, 2016updated 02 Dec 2021 12:02pm

MediciNova’s ibudilast gets FDA rare paediatric disease status to treat Krabbe disease

MediciNova has received rare paediatric disease status from the US Food and Drug Administration (FDA) for its MN-166 (ibudilast) to treat Type 1 Early Infantile Krabbe disease.

MediciNova has received rare paediatric disease status from the US Food and Drug Administration (FDA) for its MN-166 (ibudilast) to treat Type 1 Early Infantile Krabbe disease.

Krabbe disease is a rare genetic degenerative disorder, which is generally fatal before two years of age. It has four clinical subtypes, which can be distinguished by age of onset.

MN-166 is a first-in-class, orally bioavailable and small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor, which suppresses pro-inflammatory cytokines and promotes neurotrophic factors.

The ibudilast weakens activated glia cells, which plays a crucial role in certain neurological conditions.

” … We plan to work closely with the FDA and clinical experts to evaluate MN-166 in the pediatric population.”

The company also recently obtained orphan drug designation for ibudilast to treat Krabbe disease.

MediciNova president and CEO Dr Yuichi Iwaki said: “We are very pleased to receive Rare Pediatric Disease Designation for MN-166 for treatment of Krabbe disease.

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“There is an unmet medical need for treatment of Krabbe disease in the pediatric population and we plan to work closely with the FDA and clinical experts to evaluate MN-166 in the pediatric population.”

Since 1989, the company has been marketing ibudilast in Japan and Korea to treat post-stroke complications and bronchial asthma.

MediciNova received licence for ibudilast from Kyorin Pharmaceutical for use in the treatment of relapse-remitting multiple sclerosis (RRMS).

The company also obtained additional intellectual property right for ibudilast to be used for progressive MS and other neurological conditions.

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