Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014

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26/09/2014

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014

Fifteen new medicines and three extensions of indication recommended for approval

Fifteen new medicines have been recommended for approval at the September meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Committee recommended a marketing authorisation for Harvoni (sofosbuvir / ledipasvir) for the treatment of chronic hepatitis C in adults. Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. Please see the press release in the grid below for more information.

Ketoconazole HRA (ketoconazole) was recommended by the CHMP as a new treatment for patients with Cushing’s syndrome. Pharmacological options for this condition remain very limited and there is an unmet medical need for additional medicines. Ketoconazole HRA has an orphan designation. Please see the press release in the grid below for more information.

Two medicines were recommended for approval by the CHMP for the treatment of cancer: Vargatef (nintedanib) for the treatment of non-small cell lung cancer and the orphan medicine Cyramza (ramucirumab) for the treatment of gastric cancer. The diagnostic agent Lymphoseek (tilmanocept)was also recommended for the delineation and localisation of sentinel lymph nodes.

Egranli (balugrastim) was recommended by the CHMP for the treatment of chemotherapy-induced neutropenia and Rezolsta (darunavir / cobicistat)received a positive opinion for the treatment of human immunodeficiency virus (HIV).

The CHMP also recommended Trulicity (dulaglutide) for the treatment of type 2 diabetes and Moventig (naloxegol) for the treatment of opioid-induced constipation.

The generic medicine Tadalafil Mylan was recommended by the Committee for the treatment of erectile dysfunction in adult males.

The CHMP granted positive opinions for the medicines Brimica Genuair and Duaklir Genuair (aclidinium / formoterol fumarate dihydrate) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisations of both medicines.

Three hybrid applications received positive recommendations from the Committee: Budesonide / Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD, and Budesonide / Formoterol Teva Pharma B.V. for the treatment of asthma. The active ingredients in these medicines are budesonide and formoterol. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

Three recommendations on extensions of therapeutic indications

The Committee recommended an extension of indications for Signifor and two extensions of indication for Prezista.

Outcome of re-examination procedure

The CHMP concluded a re-examination procedure for Avastin, adopting a final negative opinion on a request for an extension of indication in the treatment of adult patients with newly diagnosed glioblastoma.

Review underway concerning conduct of studies at GVK Bio Research Centre, India

The EMA has started a review in relation to findings of non-compliance with good clinical practice (GCP) at GVK Biosciences site in Hyderabad, India. This follows an inspection by the French medicines agency (ANSM) which raised concerns about study data used to support the marketing authorisation applications of generic medicines.

Outcome of benefit-risk review

The CHMP has completed a routine benefit-risk review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to outweigh the risks. However, the Agency has recommended that further measures should be put in place to improve monitoring of liver function during treatment.

Closure of EU manufacturing site for Maci

The EU manufacturing site for the advanced therapy medicine Maci (matrix-applied characterised autologous cultured chondrocytes) has been closed for commercial reasons. Arrangements are in place for existing patients to complete their treatment. Please see communication in the grid below for further information.

Ebola outbreak: EMA to review experimental medicines to support treatment decisions

The EMA has started to review available information on Ebola treatments currently under development. The goal is to provide an overview of the current state of knowledge about the various experimental medicines to support decision-making by health authorities. Please see the press release in the grid below for information.

Patients discuss benefit-risk evaluation of medicines with the CHMP

The EMA has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in CHMP meetings. Please see press release for more information.

More information on all outcomes of the CHMP’s September 2014 meeting is available in the grid below.

Agenda and minutes

The agenda of the September 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the October CHMP meeting.

CHMP statistics

Key figures from the September 2014 CHMP meeting are presented in the graphic below.

 

 CHMP_highlights_September_2014
 

Positive recommendations on new medicines

Name of medicineBrimica Genuair
International non-proprietary name (INN)aclidinium / formoterol fumarate dihydrate
Marketing-authorisation applicantAlmirall S.A
Therapeutic indicationMaintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease
More informationSummary of opinion for Brimica Genuair

 

Name of medicineCyramza
INNramucirumab
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of gastric cancer
More informationSummary of opinion for Cyramza

 

Name of medicineDuaklir Genuair
INNaclidinium / formoterol fumarate dihydrate 
Marketing-authorisation applicantAlmirall S.A 
Therapeutic indicationMaintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease 
More informationSummary of opinion for Duaklir Genuair

 

Name of medicineEgranli
INNbalugrastim 
Marketing-authorisation applicantTeva Pharma B.V. 
Therapeutic indicationTreatment of chemotherapy-induced neutropenia 
More informationSummary of opinion for Egranli

 

Name of medicineHarvoni
INNsofosbuvir / ledipasvir 
Marketing-authorisation applicantGilead Sciences International Ltd 
Therapeutic indicationTreatment of chronic hepatitis C 
More informationSummary of opinion for Harvoni 
 Press release: Harvoni recommended for the treatment of chronic hepatitis C

 

Name of medicineKetoconazole HRA
INNketoconazole 
Marketing-authorisation applicantLaboratoire HRA Pharma 
Therapeutic indicationTreatment of Cushing’s syndrome 
More informationSummary of opinion for Ketoconazole HRA
 Press release: Ketoconazole HRA recommended for approval in Cushing's syndrome

 

Name of medicineLymphoseek
INNtilmanocept 
Marketing-authorisation applicantNavidea Biopharmaceuticals Limited 
Therapeutic indicationUsed in the delineation and localisation of lymph nodes 
More informationSummary of opinion for Lymphoseek 

 

Name of medicineMoventig
INNnaloxegol 
Marketing-authorisation applicantAstraZeneca AB 
Therapeutic indicationIndicated for the treatment of adult patients 18 years and older with opioid-induced constipation including patients with inadequate response to laxatives 
More informationSummary of opinion for Moventig

 

Name of medicineRezolsta
INNdarunavir / cobicistat 
Marketing-authorisation applicantJanssen-Cilag International N.V. 
Therapeutic indicationTreatment of antiretroviral therapy (ART)-naïve adults and ART-experienced adults with no darunavir (DRV) resistance associated mutations (RAMs)
More informationSummary of opinion for Rezolsta

  

Name of medicineTrulicity
INNdulaglutide
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of adults with type 2 diabetes mellitus
More informationSummary of opinion for Trulicity

 

Name of medicineVargatef
INNnintedanib
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationTreatment of non-small cell lung cancer
More informationSummary of opinion for Vargatef

 

Positive recommendation on new generic medicine 

Name of medicineTadalafil Mylan
INNtadalafil
Marketing-authorisation applicantGenerics (UK) Limited
Therapeutic indicationTreatment of erectile dysfunction in adult males
More informationSummary of opinion for Tadalafil Mylan

 

Positive recommendations on new hybrid medicines

Name of medicineBudesonide / Formoterol Teva
INNbudesonide / formoterol
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationTreatment of asthma and treatment of patients with severe chronic obstructive pulmonary disease
More informationSummary of opinion for Budesonide / Formoterol Teva

 

Name of medicineBudesonide / Formoterol Teva Pharma B.V.
INNbudesonide / formoterol
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationTreatment of asthma
More informationSummary of opinion for Budesonide / Formoterol Teva Pharma B.V.

 

Name of medicineVylaer Spiromax
INNbudesonide / formoterol
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationTreatment of asthma and treatment of patients with severe chronic obstructive pulmonary disease
More informationSummary of opinion for Vylaer Spiromax

 

Positive recommendations on extensions of therapeutic indications    

Name of medicinePrezista
INNdarunavir
Marketing-authorisation holderJanssen-Cilag International N.V.
More informationSummary of opinion for Prezista

 

Name of medicinePrezista
INNdarunavir
Marketing-authorisation holderJanssen-Cilag International N.V.
More informationSummary of opinion for Prezista

 

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

  

Negative recommendation on new extension of therapeutic indication

Name of medicineJavlor
INNvinflunine ditartrate
Marketing-authorisation holderPierre Fabre Médicament
More informationSummary of opinion for Javlor

 

Outcome of a re-examination

Name of medicineAvastin
INNbevacizumab
Marketing-authorisation holderRoche Registration Ltd
More informationQuestions and answers on Avastin

 

Start of referral 

Name of medicineGVK Biosciences
More informationStart of a review concerning the conduct of studies at GVK Biosciences site in Hyderabad, India

 

Public-health recommendations

Name of medicineValdoxan / Thymanax
INNagomelatine
Marketing-authorisation holderServier (Ireland) Industries Ltd
More informationEMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)

 

Name of medicineMaci
INNmatrix applied characterised autologous cultured chondrocytes
Marketing-authorisation holderAastrom Biosciences DK ApS
More informationClosure of EU manufacturing site for Maci

 

Outcome of harmonisation procedure

Name of medicineEMLA Cream
INNlidocaine / prilocaine
Marketing-authorisation holderAstra Zeneca group of companies and associated companies
More informationQuestions and answers on EMLA Cream

 

Opinion on any scientific matter (Article 5(3))

Name of medicineMedicinal products under development for the treatment of Ebola
More informationEbola outbreak: EMA to review experimental medicines to support treatment decisions

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Organisational matters

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