BMS and Ono Pharma's anti-PD-1 MAb receives Japanese approval

By Dan Stanton contact

- Last updated on GMT

Related tags: Bristol-myers squibb, Immune system, Monoclonal antibodies

BMS and Ono Pharma's anti-PD-1 MAb receives Japanese approval
Ono Pharmaceuticals has received approval for Opidvo (Nivolumab) in Japan becoming the first biopharma to bring a fully human PD-1 monoclonal antibody to market.

The firm has a development agreement for the drug with Bristol-Myers Squibb, who acquired Medarex in 2009​, and announced Friday it has received manufacturing and marketing approval in Japan for the treatment of unresectable melanoma.

The drug is a human monoclonal antibody, which works by blocking programmed death-1 (PD-1) - proteins that can attract programmed cell death 1 ligand 1 (PD-L1) made by cancer cells which stop T cells from attacking a tumour – and therefore overcoming the body’s immune resistance.

PD-1 inhibitors are currently being developed by a number of big biopharmas, including Novartis​, Roche, Merck & Co., AstraZeneca​, as well as Bristol-Myers Squibb, who holds the marketing rights to Opidvo outside of Japan, Korea and Taiwan.

“We are delighted to obtain a manufacturing and marketing approval as a drug targeting PD-1, which receives a lot of attention in tumor immunity, for the first time in the world​,” said Ono’s President Gyo Sagara.

“Ono would like to obtain approvals for additional indications on ongoing development for other cancers to bring many patients OPDIVO as soon as possible.”

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