Top 5 Target	Count

IFNAR(Interferon alpha/beta receptor)	1
CD49d(Integrin alpha-4)	1
JAK1(Tyrosine-protein kinase JAK1)	1
MAO-B(Monoamine oxidase B)	1
Nrf2(Nuclear factor erythroid 2-related factor 2)	1

Drugs associated with Eisai Korea, Inc.

Filgotinib Maleate

Target

JAK1

Mechanism

JAK1 inhibitors

Active Org.

Gilead Sciences, Inc. [+5]

Originator Org.

Galapagos NV

Active Indication

Colitis, Ulcerative [+8]

Inactive Indication

Arthritis, Psoriatic [+4]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

EU [+3]

First Approval Date24 Sep 2020

Safinamide mesylate

Target

MAO-B

Mechanism

MAO-B inhibitors [+1]

Active Org.

Eisai Korea, Inc. [+8]

Originator Org.

Newron Pharmaceuticals SpA

Active Indication

Parkinson Disease

Inactive Indication

Alzheimer Disease [+11]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

EU [+3]

First Approval Date23 Feb 2015

Dimethyl fumarate

Target

Nrf2

Mechanism

Nrf2 stimulants

Active Org.

Biogen Netherlands BV [+8]

Originator Org.

Biogen, Inc.

Active Indication

Plaque psoriasis [+4]

Inactive Indication

Flushing [+8]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date27 Mar 2013

Clinical Trials associated with Eisai Korea, Inc.

NCT06625242 / Not yet recruitingPhase 4

A Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Efficacy and Safety of Filgotinib in Korean Patients With Rheumatoid Arthritis

The primary purpose of this study is to assess the percentage of participants achieving an American College of Rheumatology (ACR) 20 percent (%) Improvement (ACR20) response at Week 12 of the administration of the investigational product.

Start Date15 Oct 2024

Sponsor / Collaborator

Eisai Korea, Inc.

NCT06246123 / RecruitingNot Applicable

Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects

The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Jyseleca tablet (Filgotinib Maleate) 100 milligram (mg) and 200 mg in this post marketing setting: (1) Serious adverse events and adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in precautions for use (3) Known adverse drug reactions (4) Non-serious adverse events and adverse drug reactions (5) Other safety and effectiveness related information will be evaluated in accordance with the permitted articles under the actual conditions of use in Korea.

Start Date27 Feb 2024

Sponsor / Collaborator

Eisai Korea, Inc.

NCT05533814 / Active, not recruitingPhase 4

A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures

The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).

Start Date19 Oct 2022

Sponsor / Collaborator

Eisai Korea, Inc.

100 Clinical Results associated with Eisai Korea, Inc.

0 Patents (Medical) associated with Eisai Korea, Inc.

Literatures (Medical) associated with Eisai Korea, Inc.

01 Apr 2024·Journal of Rheumatic Diseases

Real-world effectiveness of a single conventional disease-modifying anti-rheumatic drug (cDMARD) plus an anti-TNF agent versus multiple cDMARDs in rheumatoid arthritis: a prospective observational study

Article

Author: Choe, Jung-Yoon ; PharmD ; Sung, Yoon-Kyoung ; Kim, Jin Ran ; Lee, Sang-Heon ; Kim, Dong Wook ; Lee, Sang-Il ; Kim, Sang-Hyon ; Lee, Hye-Soon ; So, Min Wook ; Hur, Jin-Wuk

ObjectiveThe objective of this prospective, observational multicenter study (NCT03264703) was to compare the effectiveness of single conventional disease-modifying anti-rheumatic drug (cDMARD) plus anti-tumor necrosis factor (TNF) therapy versus multiple cDMARD treatments in patients with moderate-to-severe rheumatoid arthritis (RA) following cDMARD failure in the real-world setting in South Korea.MethodsAt the treating physicians' discretion, patients received single cDMARD plus anti-TNF therapy or multiple cDMARDs. Changes from baseline in disease activity score 28-joint count with erythrocyte sedimentation rate (DAS28-ESR), corticosteroid use, and Korean Health Assessment Questionnaire (KHAQ-20) scores were evaluated at 3, 6, and 12 months.ResultsOf 207 enrollees, the final analysis included 45 of 73 cDMARD plus anti-TNF and 91 of 134 multiple-cDMARD recipients. There were no significant between-group differences (BGDs) in ANCOVA-adjusted changes from baseline in DAS28-ESR at 3, 6 (primary endpoint), and 12 months (BGDs -0.18, -0.38, and -0.03, respectively). More cDMARD plus anti-TNF than multiple-cDMARD recipients achieved a >50% reduction from baseline in corticosteroid dosage at 12 months (35.7% vs 14.6%; p=0.007). Changes from baseline in KHAQ-20 scores at 3, 6, and 12 months were significantly better with cDMARD plus anti-TNF therapy than with multiple cDMARDs (BGD -0.18, -0.19, and -0.19 points, respectively; all p≤0.024).ConclusionIn the real-world setting, relative to multiple cDMARDs, single cDMARD plus anti-TNF therapy significantly improved quality-of-life scores and reduced corticosteroid use, with no significant BGD in disease activity, in RA patients in whom previous cDMARD therapy had failed.

01 Mar 2024·Heliyon

Treatment compliance, treatment patterns, and healthcare utilization in epilepsy patients with first add-on antiepileptic drugs: A nationwide cohort study

Article

Author: Kim, Jung-Ae ; Kim, Min Young ; Lee, Youngeun ; Lee, Sang Kun

ObjectiveThis study aimed to assess the treatment compliance, patterns, healthcare resource utilization (HCRU), and costs of anti-epilepsy drugs (AEDs) as the first add-on therapy in patients with epilepsy.MethodsWe conducted a retrospective population-based cohort study using Korean National Health Insurance claims data from 2016 to 2020. Patients with epilepsy who newly received AED add-on therapy were identified and followed for up to 12 months to evaluate persistence, adherence, treatment patterns, HCRU, and costs.ResultsAmong 6,746 patients who initiated AED add-on therapy, 65.5% were persistent on their index AED add-on from the index date until the end of the follow-up period, and the mean persistent time on the index add-on was 307.3 ± 92.3 days. A total of 76.8% patients were adherent, with a medication possession ratio (MPR) ≥80%, and the mean MPR was 88.9 ± 25.4%. Persistence and adherence to the index AED add-on were relatively higher among patients prescribed lamotrigine, levetiracetam, oxcarbazepine, and perampanel than those prescribed carbamazepine, topiramate, or valproate. A total of 41.0% of the patients changed their index AED add-on during the follow-up period. The carbamazepine, topiramate, and valproate groups had higher rates of change than the other AED groups. HCRU and costs tended to be lower in the lamotrigine, levetiracetam, oxcarbazepine, and perampanel groups. Furthermore, perampanel showed the lowest HCRU and costs for all-cause cases as well as the lowest length of stay and outpatient visits for epilepsy-related cases.ConclusionIn this population-based study, the use of lamotrigine, levetiracetam, oxcarbazepine, or perampanel as the first add-on therapy in patients with epilepsy contributed to better treatment compliance and lower HCRU and costs than that of carbamazepine, topiramate, or valproate.

01 Aug 2023·Epilepsy & behavior : E&B

Safety and effectiveness of perampanel monotherapy after adjunctive therapy through retention rate in subjects with focal-onset seizures with or without focal to bilateral tonic-clonic seizures: A multicenter retrospective study in Korea.

Article

Author: Lee, Won Gu ; Kim, Kwang Ki ; Seo, Dae-Won ; Kim, Dong Wook ; Lim, Sung Chul ; Lee, Yoona ; Park, Jihyun ; Shon, Young-Min

OBJECTIVETo assess the effectiveness and tolerability of perampanel monotherapy following conversion from adjunctive therapy.METHODSThis was a multicenter, retrospective, non-interventional study of Korean patients aged ≥12 years with focal-onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures. Data were extracted from electronic medical records of perampanel-treated patients from 1 February 2016 to 31 October 2020. Kaplan-Meier estimated retention rates, effectiveness, and safety were recorded.RESULTSSubjects (n = 66, mean age 46.2 years) were mostly male (68.2%) with focal to bilateral tonic-clonic seizure (71.2%). Mean duration of illness was 86.3 months. Retention rates after conversion to perampanel monotherapy at 3, 6, and 12 months (primary outcome) were 96.0%, 96.0%, and 75.6%, respectively. Overall retention rates in patients receiving perampanel as adjunctive or monotherapy at 3, 6, 12, 18, and 24 months after perampanel add-on were 100%, 98.3%, 95.9%, 92.6%, and 92.6%, respectively. Mean retention duration was 41.2 months (overall perampanel administration) and 21.4 months (monotherapy). Mean seizure frequency/28 days in the Full Analysis Set (n = 61) was comparable for adjunctive and monotherapy (0.2 ± 0.79 vs 0.2 ± 0.64; change between adjunctive and monotherapy periods: 0.0 ± 0.59; p = 0.498). Perampanel was well tolerated and no new safety signals were identified. Dizziness (4.6%), only reported during adjunctive therapy, was the most common treatment-emergent adverse event.CONCLUSIONSConversion to perampanel monotherapy from adjunctive therapy showed promising results in subjects with FOS with/without focal to bilateral tonic-clonic seizures; further studies in a larger population are needed to confirm these encouraging data.

News (Medical) associated with Eisai Korea, Inc.

27 May 2024

·www.pharmaceutical-technology.com

South Korea’s MFDS approves Eisai-Biogen’s LEQEMBI for Alzheimer’s

LEQEMBI is indicated for use in adults with mild cognitive impairment or mild Alzheimer’s disease (AD). Credit: fizkes / Shutterstock.com. The South Korean Ministry of Food and Drug Safety (MFDS) has granted approval for Eisai and Biogen ’s LEQEMBI (lecanemab) for use in adults with mild cognitive impairment due to mild Alzheimer’s disease (AD). This marks South Korea as the fourth nation to approve the treatment after the US, China and Japan. LEQEMBI is a humanised anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody that targets both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils) found in AD. Lecanemab is developed through a research alliance between Eisai and BioArctic. It is claimed to be the first and only treatment demonstrated to lower disease progression and slow down cognitive and functional decline. See Also: South Korea’s MFDS approves Eisai-Biogen’s LEQEMBI for Alzheimer’s EC approves Celltrion’s Omlyclo for allergic conditions Eisai is overseeing the development and regulatory submissions for LEQEMBI globally, with joint commercialisation and promotion of the product alongside Biogen. Eisai retains the final decision-making authority. In South Korea, Eisai Korea will manage the distribution and information provision activities related to LEQEMBI. Lecanemab is approved in the US to treat AD in patients with mild cognitive impairment (MCI) or mild dementia stage of the disease. The FDA’s approval of LEQEMBI was based on the data from Phase III Clarity AD clinical trial. The trial met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai also filed applications for lecanemab’s approval in 13 countries and regions, including the European Union. In the US, a supplemental biologics license application (sBLA) for intravenous maintenance dosing was submitted in March this year. Additionally, the rolling submission of a biologics license application (BLA) for a subcutaneous injection formulation began recently under fast track status, aiming to enhance patient convenience.

Drug ApprovalPhase 3Fast TrackClinical Result

100 Deals associated with Eisai Korea, Inc.

100 Translational Medicine associated with Eisai Korea, Inc.

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Pipeline

Pipeline Snapshot as of 20 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

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Safinamide mesylate ( MAO-B )	Parkinson Disease More	Approved
Filgotinib Maleate ( JAK1 )	Rheumatoid Arthritis More	Approved
Natalizumab ( CD49d )	Multiple Sclerosis, Relapsing-Remitting More	Approved
Interferon Beta-1a (Biogen, Inc.) ( IFNAR )	Multiple sclerosis relapse More	Approved
Dimethyl fumarate ( Nrf2 )	Multiple Sclerosis, Relapsing-Remitting More	Approved

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