Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

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21/07/2017

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

Eleven medicines recommended for approval, including five orphans

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its July meeting.

The CHMP recommended granting a marketing authorisation for Verkazia (ciclosporin), an orphan medicine to treat severe vernal keratoconjunctivitis in children and adolescents. This medicine was reviewed under EMA’s accelerated assessment mechanism. For more information, please see the press release in the grid below.

Four other orphan medicines were recommended for approval by the Committee: Bavencio (avelumab) for the treatment of Merkel cell carcinoma; Lutathera (lutetium [177Lu] oxodotreotide), for the treatment of gastro-entero-pancreatic neuroendocrine tumours; Rydapt (midostaurin), for the treatment of acute myeloid leukaemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukaemia; and Xermelo (telotristat ethyl), for the treatment of carcinoid syndrome.

Dupixent (dupilumab) received a positive opinion for the treatment of atopic dermatitis.

The CHMP adopted a positive opinion for Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide) for the treatment of HIV infection.

Tecentriq (atezolizumab) received a positive opinion for the treatment of locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer.

Three generic medicines received a positive opinion from the CHMP: Entecavir Accord (entecavir) and Entecavir Mylan (entecavir), both for the treatment of chronic hepatitis B; and Lacosamide Accord (lacosamide), for the treatment of epilepsy.

Negative opinions on two new medicines

The CHMP adopted a negative opinion for Fanaptum (iloperidone). Fanaptum was expected to be used to treat schizophrenia.

The Committee also adopted a negative opinion for Onzeald (etirinotecan pegol). Onzeald was intended to be used to treat breast cancer with brain metastases.

For more information on these negative opinions, please see the questions-and-answers documents in the grid below.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Bydureon, Gazyvaro, Humira, Keytruda, RoActemra, Signifor, Sovaldi and Vimpat.

Outcome of review on gadolinium contrast agents

The CHMP recommended restricting the use of some linear gadolinium agents used in magnetic resonance imaging (MRI) body scans and suspending the authorisations of others. For more information please see the public health communication in the grid below.

Re-examination of arbitration procedure

The applicant for Alcover 750 mg, 1250 mg, 1750 mg granules (sodium oxybate) has requested a re-examination of the CHMP’s June 2017 opinion. Upon receipt of the grounds for the request, the CHMP will re-examine its opinion and issue a final recommendation.

Withdrawal of application

The application for an initial marketing authorisation for Infinia (alpha-1-antitrypsin) was withdrawn. This medicine was intended to be used for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin. A questions-and-answers document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the July 2017 meeting is published on EMA’s website. Minutes of the June 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the July 2017 CHMP meeting are represented in the graphic below.

CHMP_highlights_July

Download image in pdf format

Positive recommendations on new medicines

Name of medicineBavencio
International non-proprietary name (INN)avelumab
Marketing-authorisation applicantMerck Serono Europe Ltd
Therapeutic indication

Treatment of metastatic Merkel cell carcinoma

More informationSummary of opinion for Bavencio

 

Name of medicineDupixent
INNdupilumab
Marketing-authorisation applicantSanofi-Aventis groupe
Therapeutic indicationTreatment of atopic dermatitis
More informationSummary of opinion for Dupixent

 

Name of medicineLutathera
INNlutetium (177lu) oxodotreotide
Marketing-authorisation applicantAdvanced Accelerator Applications
Therapeutic indicationTreatment of well differentiated gastroenteropancreatic neuroendocrine tumours
More informationSummary of opinion for Lutathera

 

Name of medicineRydapt
INNmidostaurin
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of acute myeloid leukaemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukaemia
More informationSummary of opinion for Rydapt

 

Name of medicineSymtuza
INNdarunavir / cobicistat / emtricitabine / tenofovir alafenamide
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of HIV infection
More informationSummary of opinion for Symtuza

 

Name of medicineTecentriq
INNatezolizumab
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer
More informationSummary of opinion for Tecentriq

 

Name of medicineVerkazia
INNciclosporin
Marketing-authorisation applicantSanten Oy
Therapeutic indicationTreatment of severe vernal keratoconjunctivitis
More informationSummary of opinion for Verkazia

Press release: New medicine for rare form of eye allergy in children and teenagers

 

Name of medicineXermelo
INNtelotristat ethyl
Marketing-authorisation applicantIpsen Pharma
Therapeutic indication

Treatment of carcinoid syndrome diarrhoea in combination with a somatostatin analogue

More informationSummary of opinion for Xermelo

 

Positive recommendations on new generic medicines

Name of medicineEntecavir Accord
INNentecavir
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of chronic hepatitis B
More informationSummary of opinion for Entecavir Accord

 

Name of medicineEntecavir Mylan
INNentecavir
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of chronic hepatitis B
More informationSummary of opinion for Entecavir Mylan

 

Name of medicineLacosamide Accord
INNlacosamide
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of epilepsy
More informationSummary of opinion for Lacosamide Accord

 

Negative recommendations on new medicines

Name of medicineFanaptum
INNiloperidone
Marketing-authorisation applicantVanda Pharmaceuticals Ltd
Therapeutic indicationTreatment of schizophrenia
More informationQuestions and answers on Fanaptum

 

Name of medicineOnzeald
INNetirinotecan pegol
Marketing-authorisation applicantNektar Therapeutics UK Ltd
Therapeutic indicationTreatment of advanced breast cancer which has spread to the brain
More informationQuestions and answers on Onzeald

 

Positive recommendations on extensions of therapeutic indications         

Name of medicineBydureon
INNexenatide
Marketing-authorisation holderAstraZeneca AB
More informationSummary of opinion for Bydureon

 

Name of medicineGazyvaro
INNobinutuzumab
Marketing-authorisation holderRoche Registration Ltd
More informationSummary of opinion for Gazyvaro

 

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbVie Ltd
More informationSummary of opinion for Humira

 

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme Ltd
More informationSummary of opinion for Keytruda

  

Name of medicineRoActemra
INNtocilizumab
Marketing-authorisation holderRoche Registration Ltd
More informationSummary of opinion for RoActemra

 

Name of medicineSignifor
INNpasireotide
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Signifor

 

Name of medicineSovaldi
INNsofosbuvir
Marketing-authorisation holderGilead Sciences International Ltd
More informationSummary of opinion for Sovaldi

  

Name of medicineVimpat
INNlacosamide
Marketing-authorisation holderUCB Pharma S.A.
More informationSummary of opinion for Vimpat

  

Public health recommendation

Name of medicineGadolinium-containing contrast agents
INNgadobenic acid / gadobutrol / gadodiamide /  gadopentetic acid / gadoteric acid / gadoteridol /  gadoversetamide / gadoxetic acid
More informationEMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans

 

Re-examination of arbitration procedure

Name of medicineAlcover 750 mg, 1250 mg, 1750 mg granules
INNsodium oxybate
Marketing-authorisation holderD&A Pharma
More informationQuestions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

 

Withdrawal of application

Name of medicineInfinia
INNalpha-1-antitrypsin 
More informationQuestions and answers on Infinia

 

Other updates

Recommendations on eligibility to PRIME scheme
Overview of (invented) names reviewed in June 2017 by the Name Review Group (NRG)
Scientific advice and protocol assistance
Start of Community reviews

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