December 1, 2023
Notification of the Approval of Home Self-injection Guidance and Management Fees and the Derestriction of the Dosing Period for NanozoraⓇ
Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; "Taisho") announced today that the TNFα Inhibitor NanozoraⓇ 30 mg Syringes for S.C. Injection ("NanozoraⓇ Syringes") and NanozoraⓇ 30 mg Autoinjectors for S.C. Injection ("NanozoraⓇ Autoinjectors") (generic name: ozoralizumab (recombinant)) were approved as drugs for home self-injection guidance and management fees and, on the same day, public medical insurance started to cover home self-injection using NanozoraⓇ Syringes and NanozoraⓇ Autoinjectors.
Taisho received approval on September 26, 2022 to manufacture and market NanozoraⓇ Syringes for rheumatoid arthritis that does not respond adequately to the current available treatments. NanozoraⓇ Syringes were included in the NHI drug price list on November 16, 2022 and marketed on December 1 of that year. Taisho received approval to manufacture and market NanozoraⓇ Autoinjectors on July 28, 2023. NanozoraⓇ Autoinjectors were included in the NHI drug price list on November 22, 2023. Taisho is currently preparing to launch the product.
Public medical insurance started to cover the home self-injection of NanozoraⓇ, and the dosing period was derestricted. This provides patients the option for home self-injection which reduces the burdens of hospital visits, in addition to the conventional in-hospital injection based on regular visits once every four weeks.
This further helps patients with rheumatoid arthritis, their families and healthcare professionals in the future.
About NanozoraⓇ
Ozoralizumab, an active ingredient of NanozoraⓇ, is an anti-TNFα NANOBODYⓇ compound initially discovered by Ablynx [Ghent (Belgium)] (currently a Sanofi company). It has a molecular weight of approximately 25% of conventional IgG antibodies. NanozoraⓇ binds to TNFα by its two subunits and potently neutralizes its activity. NanozoraⓇ also has prolonged serum half-life by interacting with human serum albumin which is highly retained in blood, enabling patients to receive treatment once every 4 weeks. Due to these positive features, NanozoraⓇ is expected to show potentially enhanced penetration to inflamed tissues and clinical efficacy even in the early stage of treatment.
* "Nanozora" is a registered trademark of Taisho Pharmaceutical Co., Ltd.
* "NANOBODY" is a registered trademark of Ablynx NV, an affiliate of Sanofi. Ablynx NV originally discovered and performed initial development of the NANOBODYⓇ compound ozoralizumab.
Product Overview
|
Brand name |
NanozoraⓇ 30 mg Syringes for S.C. Injection |
NanozoraⓇ 30 mg Autoinjectors for S.C. Injection |
|
Generic name |
Ozoralizumab (recombinant) |
|
|
Dosage form |
Injectable drug (pre-filled syringes) |
Injectable drug (autoinjectors) |
|
Indications |
Rheumatoid arthritis, which inadequately responded to the current available treatments |
|
|
Dosage and administration |
An adult patient to be treated by subcutaneously injecting 30 mg ozoralizumab (recombinant) per treatment at intervals of 4 weeks. |
|
|
Standard unit quantity |
30 mg 0.375 mL, 1 syringe |
30 mg 0.375 mL, 1 kit |
|
Drug price |
112,476 yen/syringe |
113,858 yen/kit |
|
Package |
0.375 mL (1 syringe) |
0.375 mL (1 kit) |
|
Date of approval for manufacturing and marketing |
September 26, 2022 |
July 28, 2023 |
|
Date of NHI drug price listing |
November 16, 2022 |
November 22, 2023 |
|
Date of product launch |
December 1, 2022 |
January 16, 2024 (planned) |