Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 May 2017

News 19/05/2017

Eleven medicines recommended for approval, including one advanced therapy medicine

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines, including one advanced therapy medicinal product (ATMP), for approval at its May 2017 meeting.

The CHMP recommended granting a marketing authorisation for the ATMP Spherox (spheroids of human autologous matrix-associated chondrocytes) to treat adult patients who have symptomatic articular cartilage defects in the knee where the size of the affected area is no larger than 10 cm². For more information, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Oxervate (cenegermin) for the treatment of moderate to severe neurotrophic keratitis. Oxervate has an orphan designation. For more information on this medicine, please see the press release in the grid below.

Reagila (cariprazine) received a positive opinion from the Committee for the treatment of schizophrenia.

The CHMP granted a positive opinion for Kyntheum (brodalumab) for the treatment of moderate to severe plaque psoriasis.

Trimbow (beclometasone / formoterol / glycopyrronium bromide) received a positive opinion for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

Veltassa (patiromer) received a positive opinion for the treatment of hyperkalaemia.

Four biosimilar medicines were recommended for approval by the Committee: Insulin lispro Sanofi (insulin lispro) received a positive opinion for the treatment of diabetes mellitus. Three medicines with rituximab as their active substance received a positive opinion: Blitzima and Tuxella, for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis; and Ritemvia, for the treatment of non-Hodgkin's lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis.

A biosimilar medicine is a biological medicine that is highly similar to another biological medicine already authorised for use.

One generic medicine received a positive opinion from the CHMP: Efavirenz / Emtricitabine / Tenofovir disoproxil Zentiva (efavirenz / emtricitabine / tenofovir disoproxil) for the treatment of HIV infection.

Negative opinions on three new medicines

The CHMP adopted a negative opinion for Adlumiz (anamorelin hydrochloride). Adlumiz was expected to be used to treat anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.

The Committee adopted a negative opinion for Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech. This medicine was intended to treat debilitating symptoms of advanced colorectal cancer.

The Committee also adopted a negative opinion for Masipro (masitinib). Masipro was intended to be used to treat systemic mastocytosis.

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

Six recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Izba, Komboglyze, Onglyza, Renvela, Sevelamer carbonate Zentiva and Zykadia.

Withdrawal of application

An application for an initial marketing authorisation for Qinprezo (vosaroxin) has been withdrawn. This medicine was intended to be used in combination with the cancer medicine cytarabine for the treatment of acute myeloid leukaemia. A questions-and-answers document on this withdrawal is available in the grid below.

Outcome of review on vancomycin antibiotics

The CHMP has recommended changes to the prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria. For more information please see the public health communication in the grid below.

Agenda and minutes

The agenda of the May 2017 meeting is published on EMA's website. Minutes of the April 2017 CHMP meeting will be published next week.

CHMP statistics

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

More information on all other outcomes of the CHMP's May 2017 meeting is available in the grid below.

PDF iconDownload image in pdf format

Positive recommendations on new medicines

Name of medicineKyntheum
INNbrodalumab
Marketing-authorisation applicantLEO Pharma A/S
Therapeutic indicationTreatment of moderate to severe plaque psoriasis
More information PDF iconSummary of opinion for Kyntheum

Name of medicineOxervate
INNcenegermin
Marketing-authorisation applicantDompe farmaceutici s.p.a.
Therapeutic indicationTreatment of moderate to severe neurotrophic keratitis
More information

Summary of opinion for Oxervate

Press release: New medicine for rare eye disease

Name of medicine Reagila
INNcariprazine
Marketing-authorisation applicantGedeon Richter
Therapeutic indicationTreatment of schizophrenia
More information PDF iconSummary of opinion for Reagila

Name of medicineSpherox
INNspheroids of human autologous matrix-associated chondrocytes
Marketing-authorisation applicantCO.DON AG
Therapeutic indicationRepair of certain cartilage defects of the knee
More information

Summary of opinion for Spherox

Press release: New advanced therapy to repair cartilage defects in the knee

Name of medicineTrimbow
INNbeclometasone / formoterol / glycopyrronium bromide
Marketing-authorisation applicantChiesi Farmaceutici S.p.A.
Therapeutic indicationTreatment of moderate to severe chronic obstructive pulmonary disease
More information PDF iconSummary of opinion for Trimbow

Name of medicineVeltassa
INNpatiromer
Marketing-authorisation applicantVifor Fresenius Medical Care Renal Pharma France
Therapeutic indicationTreatment of hyperkalaemia
More information PDF iconSummary of opinion for Veltassa

Positive recommendation on new generic medicine

Name of medicineEfavirenz / Emtricitabine / Tenofovir disoproxil Zentiva
INNefavirenz / emtricitabine / tenofovir disoproxil
Marketing-authorisation applicantZentiva k.s.
Therapeutic indicationTreatment of HIV infection
More information PDF iconSummary of opinion for Efavirenz / Emtricitabine / Tenofovir disoproxil Zentiva

Positive recommendations on new biosimilar medicines

Name of medicineBlitzima
INNrituximab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
Therapeutic indicationTreatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis
More information PDF iconSummary of opinion for Blitzima

Name of medicineInsulin lispro Sanofi
International non-proprietary name (INN)insulin lispro
Marketing-authorisation applicantsanofi-aventis groupe
Therapeutic indicationTreatment of diabetes mellitus
More information PDF iconSummary of opinion for Insulin lispro Sanofi

Name of medicineRitemvia
INNrituximab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
Therapeutic indicationTreatment of Non-Hodgkin's lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis
More information PDF iconSummary of opinion for Ritemvia

Name of medicineTuxella
INNrituximab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
Therapeutic indicationTreatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis
More information PDF iconSummary of opinion for Tuxella

Negative recommendations on 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 advanced 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 systemic mastocytosis
More information PDF iconQuestions and answers on Masipro

Positive recommendations on extensions of therapeutic indications

Name of medicineIzba
INNtravoprost
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Izba

Name of medicine Komboglyze
INNsaxagliptin / metformin hydrochloride
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary of opinion for Komboglyze

Name of medicineOnglyza
INNsaxagliptin
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary of opinion for Onglyza

Name of medicineRenvela
INNsevelamer carbonate
Marketing-authorisation holderGenzyme Europe BV
More information PDF iconSummary of opinion for Renvela

Name of medicineSevelamer carbonate Zentiva
INNsevelamer carbonate
Marketing-authorisation holderGenzyme Europe BV
More information PDF iconSummary of opinion for Sevelamer carbonate Zentiva

Name of medicineZykadia
INNceritinib
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Zykadia

Recommendation for new contraindication

Name of medicine Uptravi
INNselexipag
Marketing-authorisation holderActelion Registration Ltd
More information PDF iconSummary of opinion for Uptravi

Other recommendation

Name of medicine Isentress
INNraltegravir
Marketing-authorisation holderMerck Sharp & Dohme Ltd
More information PDF iconSummary of opinion for Isentress

Public health recommendation

Name of medicineVancomycin containing medicines
INNvancomycin
More informationEMA recommends changes to prescribing information for vancomycin antibiotics

Outcomes of arbitration procedures

Name of medicineCardioxane
INNdexrazoxane
Marketing-authorisation holderClinigen Group
More informationQuestions and answers on Cardioxane (dexrazoxane, powder for solution for injection, 500 mg)

Name of medicineParacetamol / Ibuprofen 500 mg / 150 mg film coated tablets and associated names
INNParacetamol / Ibuprofen 500 mg / 150 mg
Marketing-authorisation holderVale Pharmaceutical Ltd
More informationQuestions and answers on Paracetamol / Ibuprofen 500 mg / 150 mg film coated tablets and associated names

Withdrawal of application

Name of medicineQinprezo
INNvosaroxin
More information PDF iconQuestions and answers on Qinprezo

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance
Start of Community reviews

How useful was this page?

Add your rating