Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017

News 23/06/2017

Eight medicines recommended for approval, including two medicines for chronic hepatitis C virus (HCV) infection

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its June meeting.

The CHMP recommended granting marketing authorisations for Maviret (glecaprevir / pibrentasvir) and Vosevi (sofosbuvir / velpatasvir / voxilaprevir) for the treatment of chronic hepatitis C virus (HCV) infection. Both medicines were reviewed under the EU's accelerated assessment mechanism. For more information on these medicines, please see the joint press release in the grid below.

Two cancer medicines received a positive opinion from the CHMP: Kisqali (ribociclib) for the treatment of locally advanced or metastatic breast cancer and Fotivda (tivozanib) for the treatment of advanced renal cell carcinoma.

Mavenclad (cladribine) received a positive opinion for the treatment of relapsing forms of multiple sclerosis.

One biosimilar medicine was recommended for approval by the Committee: Imraldi (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis. A biosimilar medicine is a biological medicine that is highly similar to another biological medicine that is already authorised for use.

Two generic medicines received a positive opinion from the CHMP: Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan (efavirenz / emtricitabine / tenofovir disoproxil) for the treatment of HIV infection and Nitisinone MendeliKABS (nitisinone) for the treatment of hereditary tyrosinemia type 1.

Request for re-examination of three CHMP recommendations

The applicants for Adlumiz (anamorelin hydrochloride), Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech (human IgG1 monoclonal antibody specific for human interleukin-1 alpha) and Masipro (masitinib) have requested re-examinations of the Committee's negative opinions for these medicines adopted at the May 2017 meeting. The CHMP will now re-examine these opinions and issue final opinions.

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

Nine recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Faslodex, Harvoni, Kaletra, Mimpara, Orencia, Soliris, SonoVue, Stivarga and Victoza.

Withdrawals of applications

Applications for initial marketing authorisations for Elmisol (levamisole) and Zafiride (NGR-human tumour necrosis factor alpha) have been withdrawn.

Elmisol was intended to be used to treat nephrotic syndrome, a kidney disease. Zafiride was to treat patients with advanced malignant pleural mesothelioma, a cancer of the lining of the lungs usually caused by exposure to asbestos.

Questions-and-answers documents on these withdrawals are available in the grid below.

Outcome of review on Symbioflor 2

The CHMP has concluded that Symbioflor 2 can continue to be used for the treatment of irritable bowel syndrome in adults. However, the medicine should no longer be used more widely to treat functional gastrointestinal disorders, a group of disorders with a variety of causes that may require different treatment approaches. For more information, please see the public health communication in the grid below.

Agenda and minutes

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

CHMP statistics

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

PDF iconDownload image in pdf format

Positive recommendations on new medicines

Name of medicineFotivda
INNtivozanib
Marketing-authorisation applicantEusa Pharma
Therapeutic indicationTreatment of adult patients with advanced renal cell carcinoma
More information PDF iconSummary of opinion for Fotivda

Name of medicineKisqali
INNribociclib
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of breast cancer
More information PDF iconSummary of opinion Kisqali

Name of medicineMavenclad
INNcladribine
Marketing-authorisation applicantMerck Serono Europe Limited
Therapeutic indicationTreatment of relapsing forms of multiple sclerosis
More information PDF iconSummary of opinion for Mavenclad

Name of medicineMaviret
INNglecaprevir / pibrentasvir
Marketing-authorisation applicantAbbVie Ltd
Therapeutic indicationTreatment of chronic hepatitis C virus (HCV) infection
More information

PDF iconSummary of opinion for Maviret


Press release: Two new medicines recommended for the treatment of chronic hepatitis C

Name of medicineVosevi
INNsofosbuvir / velpatasvir / voxilaprevir
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of chronic hepatitis C virus (HCV) infection
More information

PDF iconSummary of opinion for Vosevi


Press release: Two new medicines recommended for the treatment of chronic hepatitis C

Positive recommendations on new generic medicines

Name of medicineEfavirenz/Emtricitabine/Tenofovir disoproxil Mylan
INNefavirenz / emtricitabine / tenofovir disoproxil
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationTreatment of HIV infection
More information PDF iconSummary of opinion for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Name of medicineNitisinone MendeliKABS
INNnitisinone
Marketing-authorisation applicantMendeliKABS Europe Ltd
Therapeutic indicationTreatment of hereditary tyrosinemia type 1
More information PDF iconSummary of opinion for Nitisinone MendeliKABS

Positive recommendation on new biosimilar medicine

Name of medicineImraldi
INNadalimumab
Marketing-authorisation applicantSamsung Bioepis UK Limited (SBUK)
Therapeutic indicationTreatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis
More information PDF iconSummary of opinion for Imraldi

Re-examination of recommendations for new medicines

Name of medicineAdlumiz
INNanamorelin hydrochloride
Marketing-authorisation applicantHelsinn Birex Pharmaceuticals Ltd
Therapeutic indicationTreatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer
More information PDF iconQuestions and answers on Adlumiz

Name of medicineHuman IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
INNhuman IgG1 monoclonal antibody specific for human interleukin-1 alpha
Marketing-authorisation applicantXBiotech Germany GmbH
Therapeutic indicationTreatment of metastatic colorectal cancer
More information PDF iconQuestions and answers on Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

Name of medicineMasipro
INNmasitinib
Marketing-authorisation applicantAB Science
Therapeutic indicationTreatment of mastocytosis
More information PDF iconQuestions and answers on Masipro

Positive recommendations on extensions of therapeutic indications

Name of medicineFaslodex
INNfulvestrant
Marketing-authorisation holderAstraZeneca UK Ltd
More information PDF iconSummary of opinion for Faslodex

Name of medicineHarvoni
INNledipasvir / sofosbuvir
Marketing-authorisation holderGilead Sciences International Ltd
More informationSummary of opinion for Harvoni

Name of medicineKaletra
INNlopinavir / ritonavir
Marketing-authorisation holderAbbVie Ltd.
More information PDF iconSummary of opinion for Kaletra

Name of medicineMimpara
INNcinacalcet
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Mimpara

Name of medicineOrencia
INNabatacept
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Orencia

Name of medicineSoliris
INNeculizumab
Marketing-authorisation holderAlexion Europe SAS
More information PDF iconSummary of opinion for Soliris

Name of medicineSonoVue
INNsulphur hexafluoride
Marketing-authorisation holderBracco International B.V.
More information PDF iconSummary of opinion for SonoVue

Name of medicineStivarga
INNregorafenib
Marketing-authorisation holderBayer Pharma AG
More information PDF iconSummary of opinion for Stivarga

Name of medicineVictoza
INNliraglutide
Marketing-authorisation holderNovo Nordisk A/S
More information PDF iconSummary of opinion for Victoza

Public health recommendation

Name of medicineSymbioflor 2 and associated names
INNEscherichia coli bacteria (cells and autolysate)
Marketing-authorisation holderSymbiopharm GmbH
More informationEMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome

Outcome 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 750 mg, 1250 mg, 1750 mg granules

Withdrawals of applications

Name of medicineElmisol
INNlevamisole
Marketing-authorisation holderACE Pharmaceuticals BV
More information PDF iconQuestions and answers on Elmisol

Name of medicineZafiride
INNNGR-human tumour necrosis factor alpha
Marketing-authorisation holderMolMed SpA
More information PDF iconQuestions and answers on Zafiride

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconOverview of (invented) names reviewed in May 2017 by the Name Review Group (NRG)
PDF iconScientific advice and protocol assistance
Start of Community reviews

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