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Nervous System Diseases	1

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SMN2(Survival motor neuron protein)	1

Multi-regional clinical trials (MRCTs) are an efficient way to enable recruitment of the planned number of subjects within a reasonable timeframe in drug development for rare diseases. One of the aim of MRCTs is to evaluate the applicability of overall trial results to a region of interest. Various statistical methods proposed for this purpose are primarily relying on regional estimates from subgroup analyses of a region of interest, thus they may not work well for studies with small sample size in rare diseases. This paper, instead, presented how to apply influence diagnostics to assessing influence of a region of interest on the overall results in MRCTs and showed this approach could be an analysis option for MRCTs in rare diseases through Monte Carlo simulation and analysis of an MRCT.

01 Jul 2019·Multiple Sclerosis Journal - Experimental, Translational and Clinical

Efficacy of dimethyl fumarate in Japanese multiple sclerosis patients: interim analysis of randomized, double-blind APEX study and its open-label extension

Article

Author: Torii, S ; Kawachi, I ; Hase, M ; Hiramatsu, K ; Yun, J ; Onizuka, Y ; Matta, A ; Kondo, T

Background Current data for the use of dimethyl fumarate (DMF) in Japanese patients with relapsing–remitting multiple sclerosis (RRMS) is limited. Objectives To assess the efficacy of DMF in Japanese patients with RRMS. Methods The phase 3, multinational APEX study (ClinicalTrials.gov identifier: NCT01838668) consisted of two parts: a 24-week double-blind part where subjects were randomized to receive DMF 240 mg or placebo twice daily in East Asian and Eastern European countries, and an open-label extension part where all subjects received DMF. The primary endpoint was the total number of new gadolinium-enhancing lesions in Weeks 12–24. In this interim analysis, we report efficacy data in the Japanese subgroup (DMF n = 56; placebo n = 58) over 72 weeks, including an extension phase. Results DMF reduced the total number of new gadolinium-enhancing lesions in Weeks 12–24 by 85% versus placebo ( p < 0.0001). At Week 24, the annualized relapse rate was also reduced by 48% with DMF, versus placebo. DMF reduced the probability of relapse from Week 8 and was sustained. The number of gadolinium-enhancing lesions was maintained through 72 weeks. Conclusions DMF demonstrated sustained efficacy in this Japanese subgroup. The results were consistent with those observed in studies of DMF enrolling primarily Caucasian patients.

01 Apr 2019·Multiple Sclerosis Journal - Experimental, Translational and Clinical

Efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with multiple sclerosis: Interim analysis of the randomized placebo-controlled study

Article

Author: Hiramatsu, Katsutoshi ; Torii, Shinichi ; Ohashi, Takashi ; Hase, Masakazu ; Matta, André ; Yun, Jang ; Onizuka, Yasuhiro ; Mori, Masahiro

Background The use of dimethyl fumarate has not been reported in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis. Objectives The purpose of this study was to evaluate the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis. Methods APEX was a phase 3, multinational trial, which consisted of a 24-week, randomized (1:1), double-blind study where patients received dimethyl fumarate 240 mg or placebo twice daily, followed by an open-label extension where all patients received dimethyl fumarate 240 mg. The primary endpoints were the total number of new gadolinium-enhancing (Gd+) lesions in Weeks 12–24 (Part I) and long-term safety (Part II). This post-hoc subgroup analysis evaluated the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis ( n=52) up to Week 72 (24 weeks Part I and 48 weeks Part II). Results Dimethyl fumarate reduced the mean total number of new gadolinium-enhancing lesions at Weeks 12–24 by 94% versus placebo; the number of patients who had a relapse over 24 weeks was reduced by 72%. Adverse events leading to discontinuation of the study drug were reported in 9% of patients receiving placebo/dimethyl fumarate and 4% of patients in dimethyl fumarate/dimethyl fumarate. Conclusions Dimethyl fumarate demonstrated sustained efficacy and acceptable tolerability in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis for 72 weeks.

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Pipeline

Pipeline Snapshot as of 08 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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