- May 22, 2018
- Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Announces the Launch in Japan of TREMFYA® Subcutaneous Injection 100mg Syringe (guselkumab), a Human Anti-interleukin (IL)-23p19 Monoclonal Antibody
Taiho Pharmaceutical Co., Ltd. announced today the launch in Japan of TREMFYA® Subcutaneous Injection 100mg Syringe (guselkumab), a human anti-interleukin (IL)-23p19 monoclonal antibody.
In March 2018, Janssen Pharmaceutical K.K. (“Janssen”) obtained manufacturing and marketing approval for TREMFYA for indications of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and erythrodermic psoriasis, which have not been effectively treated by existing treatments. The product was added to the National Health Insurance price listing today.
Based on the terms of the co-promotion agreement between Taiho Pharmaceutical and Janssen, effective December 2017, Taiho Pharmaceutical has exclusive distribution rights for TREMFYA in Japan. Taiho Pharmaceutical and Janssen will co-promote the product to medical professionals in Japan.
Taiho Pharmaceutical is committed to making greater contributions to patients and medical professionals in the field of dermatology.
TREMFYA is the first monoclonal antibody in Japan that selectively blocks p19, a protein subunit of IL-23. Psoriasis is characterized by epidermal cell overgrowth up to 30 times the normal amount, and T helper 17 cells (Th17) are thought to be greatly involved in the clinical condition. IL-23 is a cytokine involved in the differentiation, propagation, and maintenance of Th17. By binding to the p19 subunit of IL-23, TREMFYA selectively blocks IL-23 activity, inhibiting signal transmission to Th17, which is downstream from IL-23. In December 2017, Janssen filed an application in Japan for approval of the additional indication of palmoplantar pustulosis that has not been effectively treated by existing treatments. Outside Japan, the product was approved as a treatment for psoriasis in the U.S. in July 2017 and in the EU in November 2017.
|Product name||TREMFYA® Subcutaneous Injection 100mg Syringe|
|Generic name||guselkumab (genetic recombination)|
|Indications||Patients with the following diseases who do not adequately respond to conventional treatments:Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis
|Dosage and Administration||Guselkumab (genetic recombination) is administered to adults by subcutaneous injection at a dose of 100 mg at weeks 0 and 4, and then every 8 weeks thereafter.|
|Date of manufacturing and marketing approval||March 23, 2018|
|Date listed in NHI reimbursement price listing||May 22, 2018|
|Date of initial marketing in Japan||May 22, 2018|
|NHI reimbursement price||319,130 yen / syringe|
|Manufacturing distributer||Janssen Pharmaceutical K.K.|
|Sales agent||Taiho Pharmaceutical Co., Ltd.|
Information in this news release was current as of the original release date.