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
Common name | pneumococcal polysaccharide conjugate vaccine (21-valent) |
Marketing authorisation applicant | Merck Sharp & Dohme B.V. |
Therapeutic indication | Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae |
INN | datopotamab deruxtecan |
Marketing authorisation applicant | Daiichi Sankyo Europe GmbH |
Therapeutic indication | Treatment 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. |
INN | tisotumab vedotin |
Marketing authorisation applicant | Pfizer Europe MA EEIG |
Therapeutic indication | Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy |
INN | Chikungunya vaccine (recombinant, adsorbed) |
Marketing authorisation applicant | Bavarian Nordic A/S |
Therapeutic indication | Prevention 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
INN | pegfilgrastim |
Marketing authorisation applicant | CuraTeQ Biologics s.r.o. |
Therapeutic indication | Treatment of neutropenia |
INN | aflibercept |
Marketing authorisation applicant | Amgen Technology (Ireland) Unlimited Company |
Therapeutic indication | Treatment of age-related macular degeneration (AMD) and visual impairment |
INN | aflibercept |
Marketing authorisation applicant | Amgen Technology (Ireland) Unlimited Company |
Therapeutic indication | Treatment 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
INN | eltrombopag |
Marketing authorisation holder | Accord Healthcare S.L.U. |
Therapeutic indication | Treatment 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
INN | lisocabtagene maraleucel / lisocabtagene maraleucel |
Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG |
INN | durvalumab |
Marketing authorisation holder | AstraZeneca AB |
INN | nivolumab |
Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG |
INN | casirivimab / imdevimab |
Marketing authorisation holder | Roche Registration GmbH |
INN | brexpiprazole |
Marketing authorisation holder | Otsuka Pharmaceutical Netherlands B.V. |
INN | tedizolid phosphate |
Marketing authorisation holder | Merck Sharp & Dohme B.V. |
INN | melatonin |
Marketing authorisation holder | RAD Neurim Pharmaceuticals EEC SARL |
INN | ipilimumab |
Marketing authorisation holder | Bristol-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
INN | ivermectin / albendazole |
Marketing authorisation applicant | Laboratorios Liconsa S.A. |
Therapeutic indication | Treatment 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
INN | datopotamab |
Marketing authorisation applicant | Daiichi Sankyo Europe GmbH |
INN | Govorestat |
Marketing authorisation applicant | Advanz Pharma Limited |