September 26, 2022 I Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; “Taisho”) announced today that it received approval to manufacture and market NanozoraⓇ 30mg Syringes for S.C. Injection (“NanozoraⓇ“), the anti-TNFα NANOBODYⓇ therapeutic licensed from Ablynx [Ghent (Belgium)] (currently a Sanofi company) in 2015 and developed by Taisho in Japan (generic name: ozoralizumab (genetically recombined)) from the Ministry of Health, Labour and Welfare for the indication of rheumatoid arthritis (RA), which is inadequately managed by the current available treatments.
NanozoraⓇ is the first trivalent anti-TNFα NANOBODYⓇ compound approved in Japan that combines two anti-TNFα NANOBODYⓇ VHHs and one anti-serum albumin NANOBODYⓇ VHH. It takes effect following subcutaneous injection at intervals of 4 weeks. The approval of NanozoraⓇ was based on two clinical studies in Japanese patients with RA who had an inadequate response to csDMARDs. Results of the phase II/III clinical studies in patients with RA inadequately managed by methotrexate (MTX) treatments (OHZORA study) show that NanozoraⓇ demonstrated superiority over placebo in the primary endpoint ACR20 at Week 16, that is, the rate of the patients with at least a 20% improvement in the American College of Rheumatology criteria. For other efficacy endpoints, including DAS28-CRP, NanozoraⓇ demonstrated a significant reduction in disease activity from Day 3 of treatment initiation, compared to placebo. In the phase III clinical study in patients with RA not concomitantly treated with MTX (NATSUZORA study), NanozoraⓇ also showed improvement of clinical symptoms and physical functions. Throughout the clinical trials, NanozoraⓇ was well tolerated.
Taisho intends to market NanozoraⓇ and provide new treatment options for the estimated 800,000 patients with RA in Japan.
Outline of the approval
Brand name: NanozoraⓇ 30mg Syringes for S.C. Injection
Generic name: Ozoralizumab (recombinant)
Indication: Rheumatoid arthritis, which is inadequately managed by 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.
About NANOBODY® VHHs
NANOBODYⓇVHHs are molecules derived from a special type of antibody produced naturally by llamas and other camelid species. At a tenth the size of conventional antibodies, NANOBODYⓇ VHHs have the potential to reach disease targets in the human body that are inaccessible to conventional antibodies. The small, simple architecture allows the creation of “multivalent” NANOBODYⓇ compounds that can engage multiple targets at the same time by linking the individual NANOBODYⓇ VHHs together. NANOBODYⓇ therapeutics offer the possibility to replace complex treatment regimens with single, multi-action medicines for a wide range of human diseases and can be generated rapidly for large-scale production.
NANOBODYⓇ is a registered trademark of Ablynx N.V..
SOURCE: Taisho Pharmaceutical
Post Views: 64
September 26, 2022 I Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; “Taisho”) announced today that it received approval to manufacture and market NanozoraⓇ 30mg Syringes for S.C. Injection (“NanozoraⓇ“), the anti-TNFα NANOBODYⓇ therapeutic licensed from Ablynx [Ghent (Belgium)] (currently a Sanofi company) in 2015 and developed by Taisho in Japan (generic name: ozoralizumab (genetically recombined)) from the Ministry of Health, Labour and Welfare for the indication of rheumatoid arthritis (RA), which is inadequately managed by the current available treatments.
NanozoraⓇ is the first trivalent anti-TNFα NANOBODYⓇ compound approved in Japan that combines two anti-TNFα NANOBODYⓇ VHHs and one anti-serum albumin NANOBODYⓇ VHH. It takes effect following subcutaneous injection at intervals of 4 weeks. The approval of NanozoraⓇ was based on two clinical studies in Japanese patients with RA who had an inadequate response to csDMARDs. Results of the phase II/III clinical studies in patients with RA inadequately managed by methotrexate (MTX) treatments (OHZORA study) show that NanozoraⓇ demonstrated superiority over placebo in the primary endpoint ACR20 at Week 16, that is, the rate of the patients with at least a 20% improvement in the American College of Rheumatology criteria. For other efficacy endpoints, including DAS28-CRP, NanozoraⓇ demonstrated a significant reduction in disease activity from Day 3 of treatment initiation, compared to placebo. In the phase III clinical study in patients with RA not concomitantly treated with MTX (NATSUZORA study), NanozoraⓇ also showed improvement of clinical symptoms and physical functions. Throughout the clinical trials, NanozoraⓇ was well tolerated.
Taisho intends to market NanozoraⓇ and provide new treatment options for the estimated 800,000 patients with RA in Japan.
Outline of the approval
Brand name: NanozoraⓇ 30mg Syringes for S.C. Injection
Generic name: Ozoralizumab (recombinant)
Indication: Rheumatoid arthritis, which is inadequately managed by 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.
About NANOBODY® VHHs
NANOBODYⓇVHHs are molecules derived from a special type of antibody produced naturally by llamas and other camelid species. At a tenth the size of conventional antibodies, NANOBODYⓇ VHHs have the potential to reach disease targets in the human body that are inaccessible to conventional antibodies. The small, simple architecture allows the creation of “multivalent” NANOBODYⓇ compounds that can engage multiple targets at the same time by linking the individual NANOBODYⓇ VHHs together. NANOBODYⓇ therapeutics offer the possibility to replace complex treatment regimens with single, multi-action medicines for a wide range of human diseases and can be generated rapidly for large-scale production.
NANOBODYⓇ is a registered trademark of Ablynx N.V..
SOURCE: Taisho Pharmaceutical
Post Views: 64
