Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019

News 13/12/2019

Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting.

The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) for the treatment of neovascular (‘wet’) age-related macular degeneration, a disease that affects the central part of the retina at the back of the eye and causes loss of ‘straight-ahead’ vision.

The CHMP adopted a positive opinion for Recarbrio (imipenem / cilastatin / relebactam), for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

The biosimilar medicine Amsparity (adalimumab) received a positive opinion for the treatment of certain inflammatory and autoimmune disorders.

The CHMP recommended granting marketing authorisations for two generic medicines: Azacitidine Accord (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia, diseases in which the body produces large numbers of abnormal blood cells; and Dexmedetomidine Accord (dexmedetomidine), for the induction of light to moderate sedation of adults in an intensive care unit.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Akynzeo, Cyramza, Darzalex, Dificlir, Erleada, Sirturo, Stelara and Vyndaqel.

Agenda and minutes

The agenda of the December meeting is published on EMA's website. Minutes of the November 2019 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the December 2019 CHMP meeting are represented in the graphic below.

CHMP statistics: December 2019

 

Positive recommendations on new medicines

Name of medicineBeovu
INNbrolucizumab
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indicationTreatment of neovascular (wet) age-related macular degeneration (AMD)
More information

 

Name of medicineRecarbrio
INNimipenem / cilastatin / relebactam
Marketing-authorisation applicantMerck Sharp & Dohme B.V.
Therapeutic indicationTreatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options
More informationRecarbrio: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineAmsparity
International non-proprietary name (INN)adalimumab
Therapeutic indicationTreatment of certain inflammatory and autoimmune disorders
Marketing-authorisation applicantPfizer Europe MA EEIG
More information

 

Positive recommendations on new generic medicines

Name of medicineAzacitidine Accord
INNazacitidine
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia
More information

 

Name of medicineDexmedetomidine Accord
INNdexmedetomidine
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationInduction of light to moderate sedation of adults in intensive care unit
More information

 

Positive recommendations on extensions of indications

Name of medicineAkynzeo
INNfosnetupitant / palonosetron
Marketing-authorisation holderHelsinn Birex Pharmaceuticals Limited
More information

 

Name of medicineCyramza
INNramucirumab
Marketing-authorisation holderEli Lilly Nederland B.V.
More information

 

Name of medicineDarzalex
INNdaratumumab
Marketing-authorisation holderJanssen-Cilag International NV
More information

 

Name of medicineDificlir
INNfidaxomicin
Marketing-authorisation holderAstellas Pharma Europe B.V.
More informationDificlir: Pending EC decision

 

Name of medicineErleada
INNapalutamide
Marketing-authorisation holderJanssen-Cilag International N.V.
More information

 

Name of medicineSirturo
INNbedaquiline
Marketing-authorisation holderJanssen-Cilag International NV
More information

 

Name of medicineStelara
INNustekinumab
Marketing-authorisation holderJanssen-Cilag International NV
More information

 

Name of medicineVyndaqel
INNtafamidis
Marketing-authorisation holderPfizer Europe MA EEIG
More information

 

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