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NS Pharma’s NS-089/NCNP-02 gains FDA rare paediatric disease status

2023-07-10

孤儿药寡核苷酸临床2期

NS Pharma’s NS-089/NCNP-02 (brogidirsen) is intended for patients with Duchenne muscular dystrophy. Credit: Jose Luis Calvo via Shutterstock.com.

NS Pharmaod NS-089/NCNP-02istration (FDA) has awarded rare paediatric dDuchenne muscular dystrophy NS Pharma’s investigational therapy, NS-089/NCNP-02 (brogidirsen), to treat Duchenne muscular dystrophy.

The conFood and Drug Administration (FDA)ipping therapy.NS Pharma NS-089/NCNP-02 brogidirsen Duchenne muscular dystrophy

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NS-089/NCNP-02 is an antisense nucleotide discovered in collaborative research between the National Center for Psychiatry and Neurological Medicine and Nippon Shinyaku, the parent firm of NS Pharma.

The drug candidate’s clinicaTriamcinolone Acetonide a PDiabetic Macular Edema to be carried out in the US by NS Pharma and a Phase II study to be conducted by Nippon Shinyaku in Japan.

NS Pharma will provide further trial data once subject enrolment has commenced.

NS-089/NCNP-02 agency granted RPD status for therapies that could potentially treat serious or life-threatening ailments affecting 200,000 US patients wNippon Shinyaku or younger.NS Pharma

Duchenne is a progressive type of muscular dystrophy seen primarily in men. It leads to gradual weakness and NS Pharma cardiac and respiratory muscle loss.Nippon Shinyaku

NS Pharmaer 2022, NS Pharma received orphan drug status from the US FDA for an investigational candidate, NS-018 (ilginatinib), to treat myelofibrosis, a rare type of blood cancer.

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