Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 May 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 dipropionate / formoterol fumarate dihydrate / glycopyrronium) 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.

Download image in pdf format

Name of medicine Kyntheum
INN brodalumab
Marketing-authorisation applicant LEO Pharma A/S
Therapeutic indication Treatment of moderate to severe plaque psoriasis
More information Summary of opinion for Kyntheum
Name of medicine Oxervate
INN cenegermin
Marketing-authorisation applicant Dompe farmaceutici s.p.a.
Therapeutic indication Treatment 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
INN cariprazine
Marketing-authorisation applicant Gedeon Richter
Therapeutic indication Treatment of schizophrenia
More information Summary of opinion for Reagila
Name of medicine Spherox
INN spheroids of human autologous matrix-associated chondrocytes
Marketing-authorisation applicant CO.DON AG
Therapeutic indication Repair 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 medicine Trimbow
INN beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation applicant Chiesi Farmaceutici S.p.A.
Therapeutic indication Treatment of moderate to severe chronic obstructive pulmonary disease
More information Summary of opinion for Trimbow
Name of medicine Veltassa
INN patiromer
Marketing-authorisation applicant Vifor Fresenius Medical Care Renal Pharma France
Therapeutic indication Treatment of hyperkalaemia
More information Summary of opinion for Veltassa
Name of medicine Efavirenz / Emtricitabine / Tenofovir disoproxil Zentiva
INN efavirenz / emtricitabine / tenofovir disoproxil
Marketing-authorisation applicant Zentiva k.s.
Therapeutic indication Treatment of HIV infection
More information Summary of opinion for Efavirenz / Emtricitabine / Tenofovir disoproxil Zentiva
Name of medicine Blitzima
INN rituximab
Marketing-authorisation applicant Celltrion Healthcare Hungary Kft.
Therapeutic indication Treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis
More information Summary of opinion for Blitzima
Name of medicine Insulin lispro Sanofi
International non-proprietary name (INN) insulin lispro
Marketing-authorisation applicant sanofi-aventis groupe
Therapeutic indication Treatment of diabetes mellitus
More information Summary of opinion for Insulin lispro Sanofi
Name of medicine Ritemvia
INN rituximab
Marketing-authorisation applicant Celltrion Healthcare Hungary Kft.
Therapeutic indication Treatment of Non-Hodgkin's lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis
More information Summary of opinion for Ritemvia
Name of medicine Tuxella
INN rituximab
Marketing-authorisation applicant Celltrion Healthcare Hungary Kft.
Therapeutic indication Treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis
More information Summary of opinion for Tuxella
Name of medicine Adlumiz 
INN anamorelin hydrochloride
Marketing-authorisation applicant Helsinn Birex Pharmaceuticals Ltd
Therapeutic indication Treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer
More information Questions and answers on Adlumiz
Name of medicine Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech 
INN human IgG1 monoclonal antibody specific for human interleukin-1 alpha
Marketing-authorisation applicant XBiotech Germany GmbH
Therapeutic indication Treatment of advanced colorectal cancer
More information Questions and answers on Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
Name of medicine Masipro
INN masitinib
Marketing-authorisation applicant AB Science
Therapeutic indication Treatment of systemic mastocytosis
More information Questions and answers on Masipro
Name of medicine Izba 
INN travoprost
Marketing-authorisation holder Novartis Europharm Ltd
More information Summary of opinion for Izba
Name of medicine  Komboglyze
INN saxagliptin / metformin hydrochloride
Marketing-authorisation holder AstraZeneca AB
More information Summary of opinion for Komboglyze
Name of medicine Onglyza
INN saxagliptin
Marketing-authorisation holder AstraZeneca AB
More information Summary of opinion for Onglyza
Name of medicine Renvela
INN sevelamer carbonate
Marketing-authorisation holder Genzyme Europe BV
More information Summary of opinion for Renvela to be published shortly
Name of medicine Sevelamer carbonate Zentiva
INN sevelamer carbonate
Marketing-authorisation holder Genzyme Europe BV
More information Summary of opinion for Sevelamer carbonate Zentiva to be published shortly
Name of medicine Zykadia 
INN ceritinib
Marketing-authorisation holder Novartis Europharm Ltd
More information Summary of opinion for Zykadia
Name of medicine  Uptravi
INN selexipag
Marketing-authorisation holder Actelion Registration Ltd
More information Summary of opinion for Uptravi
Name of medicine  Isentress
INN raltegravir
Marketing-authorisation holder Merck Sharp & Dohme Ltd
More information Summary of opinion for Isentress
Name of medicine Vancomycin containing medicines
INN vancomycin
More information EMA recommends changes to prescribing information for vancomycin antibiotics
Name of medicine Cardioxane
INN dexrazoxane
Marketing-authorisation holder Clinigen Group
More information Questions and answers on Cardioxane (dexrazoxane, powder for solution for injection, 500 mg)
Name of medicine Paracetamol / Ibuprofen 500 mg / 150 mg film coated tablets and associated names
INN Paracetamol / Ibuprofen 500 mg / 150 mg
Marketing-authorisation holder Vale Pharmaceutical Ltd
More information Questions and answers on Paracetamol / Ibuprofen 500 mg / 150 mg film coated tablets and associated names
Name of medicine Qinprezo
INN vosaroxin
More information Questions and answers on Qinprezo
Recommendations on eligibility to PRIME scheme
Scientific advice and protocol assistance
Start of Community reviews

To read more Press Release articles, click here.