Kyowa Kirin : Announces Application for Additional Formulation of “LUMICEF® Subcutaneous Injection 210 mg Pen” in Japan

Kyowa Kirin Announces Application for Additional Formulation of

"LUMICEF® Subcutaneous Injection 210 mg Pen" in Japan

Tokyo, Japan, June 28, 2024 --Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced that the company has filed an application for an additional formulation of LUMICEF® [KHK4827, generic name: brodalumab (genetical recombination)], LUMICEF® Subcutaneous Injection 210 mg Pen in Japan on June 28th.

The current approved formulation, LUMICEF® Subcutaneous Injection 210 mg Syringe was approved in July 2016 for the treatment of psoriasis (psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma) that responds inadequately to existing therapies in Japan. LUMICEF® was also approved for the additional indications of ankylosing spondylitis and non-radiographic axial spondylarthritis that respond inadequately to existing therapies in November 2020, and palmoplantar pustulosis that respond inadequately to existing therapies in August 2023. LUMICEF® is the only approved anti-interleukin-17(IL-17) receptor A (IL-17RA） antibody for these indications. "LUMICEF® Subcutaneous Injection 210 mg Pen" is a pen-type auto injector that infuses the same composition as "LUMICEF® Subcutaneous Injection 210 mg Syringe". It is expected to improve self-administration safety and convenience for patients.

LUMICEF® is a fully human anti-IL-17RA antibody that inhibits biological activity of inflammatory cytokines such as IL-17A,IL-17A/F,IL-17F and epidermal cell derived IL-17C by binding to IL- 17RA selectively. It has been shown to have a rapid onset of effect in clinical trials, long-termsafety1-3, and an impact on patient-reported outcome (PRO)* in real-world clinical settings4-12.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

* About Patient-Reported Outcome

It refers to the patient's own evaluation and report of symptoms and complaints, rather than an evaluation by the physician. Symptoms involving subjective judgments are sometimes misaligned between the physician's and the patient's evaluations. Incorporating the patient's own evaluation will lead to a correct assessment of the drug's efficacy.

Reference

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2. Nakagawa H, et al. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016; 81(1) : 44-52.
3. Lebwohl M. G., et al. Efficacy, safety, and patient-reported outcomes in patients with moderate-to- severe plaque psoriasis treated with brodalumab for 5 years in a long-term,open-label, phase II study. Am. J. Clin. Dermatol. 2019; 20: 863-871.
4. Imafuku S, et al. Utility of the Dermatology Life Quality Index at initiation or switching of biologics in real-life Japanese patients with plaque psoriasis: Results from the ProLOGUE study. J Dermatol Sci. 2021; 101(3): 185-193.
5. Imafuku S, et al. Effectiveness of brodalumab in achieving treatment satisfaction for patients with plaque psoriasis: The ProLOGUE study. J Dermatol Sci. 2022; 105(3): 176-184.
6. Miyagi T, et al. Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm,open-label, multicenter, prospective ProLOGUE study. JAAD Int. 2022; 8: 146-153.
7. Ohata C, et al. Difference in health-related quality of life between anxiety and depressive symptoms in Japanese patients with plaque psoriasis: the ProLOGUE study. J Eur Acad Dermatol Venereol. 2022; 36(1): e57-e59.
8. Ohata C, et al. Effectiveness of long-term treatment with brodalumab on anxiety or depressive symptoms in Japanese patients with psoriasis: the ProLOGUE study. Dermatol Ther (Heidelb). 2023; 13: 1039-1052.
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   ProLOGUE study. J Dermatol Sci. 2022; 105(3): 189-191.
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12. Saeki H, et al. Work productivity in real-life employed patients with plaque psoriasis: Results from the
    ProLOGUE study. J Dermatol. 2022; 49(10): 970-978.