Mitsubishi Tanabe Pharmaceutical's CD19 monoclonal antibody Uplizna approved in Japan

Mitsubishi Tanabe Pharmaceutical Company (MTPC) recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the anti-CD19 monoclonal antibody Uplizna (MEDI-551, generic name: inebilizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD, optic nerve spinal cord) Inflammation) patients to prevent the recurrence of the disease.

NMOSD is an autoimmune disease of the central nervous system, characterized by severe optic neuritis and transverse myelitis, and is a refractory disease.

Uplizna is a humanized anti-CD19 monoclonal antibody, licensed by MTPC from Viela Bio, and has the right to develop and commercialize Uplizna therapy in Japan, Thailand, Korea, Indonesia, Vietnam, Malaysia, the Philippines, Singapore, and Taiwan.

In June 2020, Uplizna received the world's first regulatory approval in the United States: as a maintenance regimen twice a year after the initial dose, it is used to treat anti-aquaporin-4 (AQP4) antibody-positive NMOSD adult patients.

It is worth mentioning that Uplizna is the first and only B cell depleting agent approved for the treatment of AQP4 antibody-positive adult patients with NMOSD.

At the end of May 2019, Hansoh Pharma and Viela Bio reached a strategic cooperation to develop inebilizumab in China to treat NMOSD and other potential inflammatory/autoimmune and hematological malignancies indications.

The mechanism of action of Uplizna's active pharmaceutical ingredient inebilizumab (MEDI-551)

This approval is based on data from the key global clinical study N-MOmentum conducted by Viela Bio, which is a large-scale study conducted in adult patients (including Japanese patients) of the real-world lineage of NMOSD.

According to the recommendations of the Independent Data Monitoring Committee (IDMC) and based on evidence of efficacy, the study ended early.

The study also reached key secondary endpoints: Compared with placebo, inebilizumab significantly reduced disability deterioration (15.

NMOSD is a rare, destructive, complement-mediated autoimmune disease of the central nervous system.

In terms of NMOSD treatment, Alexion's first C5 complement inhibitor Soliris (eculizumab) was approved in 2019, becoming the first drug approved for the treatment of NMOSD.

In 2020, Roche IL-6R monoclonal antibody Enspryng (satralizumab) was approved for marketing, becoming the second drug approved for the treatment of NMOSD.

Original source: Manufacturing and Marketing approval of UPLIZNA for IV Infusion 100mg for the Treatment of Neuromyelitis Optica Spectrum Disorder in Japan-FirstWord Pharma