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Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for the Indication of Amyotrophic Lateral Sclerosis

Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for the Indication of Amyotrophic Lateral Sclerosis
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Stefan klotterEisai co ltdTokushima universityDevices agencyTokushima university graduate school of biomedical sciencesMinistry of healthDepartment of neurologyPublic relations departmentChiba university graduate school of medicineWelfare specified disease treatment research programNew drug applicationMedical devices agencyJapan early stage trialUltrahigh dose methylcobalaminExtraordinary professor ryuji kajiPrincipal investigator

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Eisai co ltdPublic relations departmentMinistry of healthDevices agencyWelfare specified disease treatment research programTokushima university graduate school of biomedical sciencesChiba university graduate school of medicineDepartment of neurologyTokushima universitySubmits new drug applicationMecobalamin ultrahigh dose formulationAmyotrophic lateralNew drug applicationMedical devices agencyJapan early stage trialUltrahigh dose methylcobalamin

Eisai: MHLW Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of ALS

TOKYO, May 27, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression

Eisai co ltdTokushima universityDepartment of neurologyTokushima university graduate school of biomedical sciencesPublic relations departmentMinistry of healthJapan early stage trialUltrahigh dose methylcobalaminExtraordinary professor ryuji kajiPrincipal investigatorProfessor yuishin izumiCoordinating investigatorTokushima university graduate schoolBiomedical sciencesRelations department

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Eisai co ltdTokushima universityDepartment of neurologyTokushima university graduate school of biomedical sciencesMinistry of healthPublic relations departmentOrphan drug designationMecobalamin ultrahigh dose formulationProspective indicationFunctional impairmentJapan early stage trialUltrahigh dose methylcobalaminExtraordinary professor ryuji kajiPrincipal investigatorProfessor yuishin izumiCoordinating investigator

Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan

TOKYO, May 10, 2022 - (JCN Newswire) - Eisai Co., Ltd. today announced that it has initiated preparation on a New Drug Application for ultrahigh-dose mecobalamin (development code: E0302) for amyotrophic

Welfare specified disease treatment research programTokushima universityDepartment of neurologyTokushima university graduate school of biomedical sciencesMinistry of healthEisai co ltdPublic relations departmentJapan agency for medical researchDevices agencyNew drug applicationJapan early stage trialUltrahigh dose methylcobalaminExtraordinary professor ryuji kajiPrincipal investigatorProfessor yuishin izumiCoordinating investigator