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

News 29/04/2016

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 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

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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 information PDF iconSummary of opinion for EndolucinBeta

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

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

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

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

PDF iconSummary 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

PDF iconSummary 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 information PDF iconSummary of opinion for Zinbryta

Negative recommendation on new medicine

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

Positive recommendations on extensions of therapeutic indications

Name of medicineAfinitor
INNeverolimus
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Afinitor

Name of medicineAvastin
INNbevacizumab
Marketing-authorisation holderRoche Registration Limited
More information PDF iconSummary of opinion for Avastin

Name of medicineFerriprox
INNdeferiprone
Marketing-authorisation holderApotex Europe BV
More information PDF iconSummary of opinion for Ferriprox

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

PDF iconSummary 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 information PDF iconSummary of opinion for HyQvia

Name of medicineImbruvica
INNibrutinib
Marketing-authorisation holderJanssen-Cilag International NV
More information PDF iconSummary of opinion for Imbruvica

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

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

Name of medicineZinforo
INNceftaroline fosamil
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary 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

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in April 2016 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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