EMA、2025年1月に8つの新薬を承認勧告

2025年2月3日

 

欧州医薬品庁(European Medicines Agency:EMA)のヒト医薬品委員会( human medicines committee:CHMP)は、2025年1月31日、2025年1月の会合で医薬品承認等を勧告したことを発表した。この中には、3つのバイオシミラーと1つの新規ジェネリック医薬品も含まれている。また、EUで承認されている8つの医薬品について、効能・効果の延長も勧告している。一方、2つの医薬品の初回製造販売承認申請が取り下げられ、この中には、第一三共のDatopotamab deruxtecanも含まれる。

ニュースソース
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2025?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-9BeP1g_ukMXitJi1tKXHshviHkOlLMoXjfGLtCOVt1TWMU0jeZoEfzm5WEy2QFmven1z2okpXr3sFRgIvY7WHdIqqyjZ_DJZ8txUzODNUpbVuh6DU&_hsmi=345106560&utm_content=345106560&utm_source=hs_email

 

新薬に関するポジティブな推奨 Positive recommendations on new medicines
  • Capvaxive
Common namepneumococcal polysaccharide conjugate vaccine (21-valent)
Marketing authorisation applicantMerck Sharp & Dohme B.V.
Therapeutic indicationActive immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae
  • Datroway
INNdatopotamab deruxtecan
Marketing authorisation applicantDaiichi Sankyo Europe GmbH
Therapeutic indicationTreatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting.
  • Tivdak
INNtisotumab vedotin
Marketing authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationTreatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy
  • Vimkunya
INNChikungunya vaccine (recombinant, adsorbed)
Marketing authorisation applicantBavarian Nordic A/S
Therapeutic indicationPrevention of disease caused by chikungunya (CHIKV) virus
バイオシミラー新薬へのポジティブな勧告 Positive recommendations on new biosimilar medicines
  • Dyrupeg
INNpegfilgrastim
Marketing authorisation applicantCuraTeQ Biologics s.r.o.
Therapeutic indicationTreatment of neutropenia
  • Pavblu
INNaflibercept
Marketing authorisation applicantAmgen Technology (Ireland) Unlimited Company
Therapeutic indicationTreatment of age-related macular degeneration (AMD) and visual impairment
  • Skojoy
INNaflibercept
Marketing authorisation applicantAmgen Technology (Ireland) Unlimited Company
Therapeutic indicationTreatment of age-related macular degeneration (AMD) and visual impairment
新ジェネリック医薬品へのポジティブな勧告 Positive recommendation on new generic medicine
  • Eltrombopag Accord
INNeltrombopag
Marketing authorisation holderAccord Healthcare S.L.U.
Therapeutic indicationTreatment of primary immune thrombocytopenia (ITP), chronic hepatitis C virus (HCV)
新たな治療適応についてポジティブな勧告     Positive recommendations on new therapeutic indications
  • Breyanzi
INNlisocabtagene maraleucel / lisocabtagene maraleucel
Marketing authorisation holderBristol-Myers Squibb Pharma EEIG
  • Imfinzi
INNdurvalumab
Marketing authorisation holderAstraZeneca AB
  • Opdivo
INNnivolumab
Marketing authorisation holderBristol-Myers Squibb Pharma EEIG
  • Ronapreve
INNcasirivimab / imdevimab
Marketing authorisation holderRoche Registration GmbH
  • Rxulti
INNbrexpiprazole
Marketing authorisation holderOtsuka Pharmaceutical Netherlands B.V.
  • Sivextro
INNtedizolid phosphate
Marketing authorisation holderMerck Sharp & Dohme B.V.
  • Slenyto
INNmelatonin
Marketing authorisation holderRAD Neurim Pharmaceuticals EEC SARL
  • Yervoy
INNipilimumab
Marketing authorisation holderBristol-Myers Squibb Pharma EEIG

 

EU域外での使用を意図した医薬品へのポジティブな勧告 Positive opinions for medicines intended for use outside the EU
  • Ivermectin / Albendazole
INNivermectin / albendazole
Marketing authorisation applicantLaboratorios Liconsa S.A.
Therapeutic indicationTreatment of soil-transmitted helminth infections, treatment of microfilaraemia in patients with lymphatic filariasis
初回製造販売承認申請の取り下げ Withdrawal of initial marketing authorisation application
  • Datopotamab deruxtecan Daiichi Sankyo
INNdatopotamab
Marketing authorisation applicantDaiichi Sankyo Europe GmbH
  • Nugalviq
INN Govorestat
Marketing authorisation applicantAdvanz Pharma Limited

 

2025年2月3日
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