Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016

  • Email
  • Help

News

29/04/2016

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016

Six medicines, including one new antibacterial recommended for authorisation in the EU; antiseptic gel for newborns receives positive scientific opinion for use outside the EU

At its April meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Umbipro (chlorhexidine digluconate), an antiseptic gel to prevent umbilical cord infections (omphalitis) in newborn babies, for use in countries outside the European Union (EU).

Umbipro was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low-income countries outside the EU. For more information on Umbipro and the Article 58 procedure, please see the press release and infographic in the grid below.

In addition, six medicines were recommended for marketing authorisation in the EU. These recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation:

Zavicefta (ceftazidime / avibactam), a new treatment option against multi-drug resistant bacteria was recommended for approval by the Committee. The medicine is to be used in adult patients with intra-abdominal infection, urinary tract infection, as well as pneumonia acquired in a hospital setting. It is also indicated for the treatment of adults with infections caused by certain Gram-negative bacteria, for which there are only limited treatment options. For more information on Zavicefta, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Zinbryta (daclizumab) for the treatment of relapsing forms of multiple sclerosis.

Ongentys (opicapone) received a positive opinion from the Committee for the treatment of Parkinson’s disease and motor fluctuations.

The CHMP gave a positive opinion for Odefsey (emtricitabine / rilpivirine / tenofovir alafenamide) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Enzepi (pancreas powder) received a positive opinion for the treatment of exocrine pancreatic insufficiency.

EndolucinBeta (lutetium (177 lu) chloride) also received a positive opinion. It is a radiopharmaceutical precursor that has to be combined with another medicine, a carrier medicine, in a process called radiolabelling before administration. The carrier medicine then takes EndolucinBeta to the disease site in the body where it gives off beta-radiation, allowing a localised radiation effect.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Sialanar (glycopyrronium bromide). Sialanar was intended for the treatment of persistent drooling in children and adolescents with neurological conditions. For more information, please see the questions-and-answers document in the grid below.

Nine recommendations on extensions of therapeutic indications

The Committee recommended adding treatment of follicular lymphoma to the approved indication for Gazyvaro. For more information on Gazyvaro, please see the press release in the grid below.

The CHMP also recommended extensions of indications for Afinitor, Avastin, Ferriprox, HyQvia, Imbruvica, Reyataz, Victoza and Zinforo.

Start of review on the conduct of studies at Semler Research Centre Private Ltd

The CHMP has started a review of medicines for which studies have been conducted at Semler Research Centre Private Ltd in Bangalore, India. This follows inspections by the FDA and the World Health Organization which raised serious concerns over data generated at Semler’s sites. For more information, please see the start of referral documents in the grid below.

Outcome of review of inhaled corticosteroids for chronic obstructive pulmonary disease

The Committee completed its review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD). The review confirmed the known risk of pneumonia with these products, but did not find conclusive evidence of differences in this risk between different products in this class. For more information, please see the public health communication in the grid below.

Agenda and minutes

The agenda of the April 2016 meeting is published on EMA’s website. Minutes of the March 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the April 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s April 2016 meeting, is available in the grid below.

CHMP statistics: April 2016

Download image in PDF format

 

Positive recommendations on new medicines

Name of medicineEndolucinBeta
INNlutetium (177 lu) chloride 
Marketing-authorisation applicantITG Isotope Technologies Garching GmbH 
Therapeutic indicationRadiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride
More informationSummary of opinion for EndolucinBeta

 

Name of medicineEnzepi
INNpancreas powder 
Marketing-authorisation applicantAptalis Pharma SAS 
Therapeutic indicationTreatment of exocrine pancreatic insufficiency 
More informationSummary of opinion for Enzepi

 

Name of medicineOdefsey
INNemtricitabine / rilpivirine / tenofovir alafenamide 
Marketing-authorisation applicantGilead Sciences International Ltd 
Therapeutic indicationTreatment of HIV-1
More informationSummary of opinion for Odefsey

 

Name of medicineOngentys
INNopicapone
Marketing-authorisation applicantBial - Portela & Cª, S.A. 
Therapeutic indicationParkinson’s disease and motor fluctuations
More informationSummary of opinion for Ongentys

 

Name of medicineUmbipro
INNchlorhexidine 
Marketing-authorisation applicantGlaxoSmithKline Trading Services 
Therapeutic indicationProphylaxis of omphalitis  
More information

Summary of opinion for Umbipro

 

Press release: Boosting care for newborn babies in low-income countries

 

Name of medicineZavicefta
INNceftazidime / avibactam 
Marketing-authorisation applicantAstraZeneca AB 
Therapeutic indicationTreatment in adults of complicated Intra-Abdominal Infection, complicated urinary tract infection, including pyelonephritis, hospital-acquired pneumonia, including ventilator associated pneumonia, infections due to aerobic Gram-negative organisms in patients with limited treatment options
More information

Summary of opinion for Zavicefta

 

Press release: New medicine to help in the fight against antimicrobial resistance

 

Name of medicineZinbryta
INNdaclizumab 
Marketing-authorisation applicantBiogen Idec Ltd 
Therapeutic indicationTreatment of relapsing forms of multiple sclerosis
More informationSummary of opinion for Zinbryta

 

Negative recommendation on new medicine

Name of medicineSialanar
INNglycopyrronium bromide 
Marketing-authorisation applicantProveca Limited 
Therapeutic indicationTreatment of sialorrhoea 
More informationQuestions and answers on Sialanar

  

Positive recommendations on extensions of therapeutic indications

Name of medicineAfinitor
INNeverolimus 
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Afinitor

  

Name of medicineAvastin
INNbevacizumab 
Marketing-authorisation holderRoche Registration Limited
More informationSummary of opinion for Avastin

 

Name of medicineFerriprox
INNdeferiprone 
Marketing-authorisation holderApotex Europe BV
More informationSummary of opinion for Ferriprox

 

Name of medicineGazyvaro
INNobinutuzumab 
Marketing-authorisation holderRoche Registration Limited 
More information

Summary of opinion for Gazyvaro

 

Press release: New treatment for rare white blood cell cancer

  

Name of medicineHyQvia
INNhuman normal immunoglobulin 
Marketing-authorisation holderBaxalta Innovations GmbH
More informationSummary of opinion for HyQvia

 

Name of medicineImbruvica
INNibrutinib 
Marketing-authorisation holderJanssen-Cilag International NV
More informationSummary of opinion for Imbruvica

   

Name of medicineReyataz
INNatazanavir / atazanavir sulfate 
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationSummary of opinion for Reyataz

   

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

  

Name of medicineZinforo
INNceftaroline fosamil 
Marketing-authorisation holderAstraZeneca AB 
More informationSummary of opinion for Zinforo

 

Start of procedure

Name of medicineSemler
More informationStart of a review on the conduct of studies at Semler Research Centre Private Ltd, Bangalore, India

 

Public health recommendation

Name of medicineInhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
More informationEMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease

 

Outcome of harmonisation procedure

Name of medicine Novantrone and associated names
INNmitoxantrone 
Marketing-authorisation holderMEDA group of companies and associated companies 
More informationQuestions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion)

 

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
Overview of invented names reviewed in April 2016 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices 

How helpful is this page?

Average rating:

 Based on 4 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
4 ratings
    

Tell us more

Related document

Related content

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu
Follow us on Twitter @EMA_News