Home Medical News EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016
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EMA

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

London, UK (April 29, 2016) - 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_highlights_April_2016.png



Positive recommendations on new medicines


Name of medicine

EndolucinBeta

INN

lutetium (177 lu) chloride

Marketing-authorisation applicant

ITG Isotope Technologies Garching GmbH

Therapeutic indication

Radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride

More information

Summary of opinion for EndolucinBeta


Name of medicine

Enzepi

INN

pancreas powder

Marketing-authorisation applicant

Aptalis Pharma SAS

Therapeutic indication

Treatment of exocrine pancreatic insufficiency

More information

Summary of opinion for Enzepi


Name of medicine

Odefsey

INN

emtricitabine / rilpivirine / tenofovir alafenamide

Marketing-authorisation applicant

Gilead Sciences International Ltd

Therapeutic indication

Treatment of HIV-1

More information

Summary of opinion for Odefsey


Name of medicine

Ongentys

INN

opicapone

Marketing-authorisation applicant

Bial - Portela & Cª, S.A.

Therapeutic indication

Parkinson’s disease and motor fluctuations

More information

Summary of opinion for Ongentys


Name of medicine

Umbipro

INN

chlorhexidine

Marketing-authorisation applicant

GlaxoSmithKline Trading Services

Therapeutic indication

Prophylaxis of omphalitis

More information

Summary of opinion for Umbipro

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


Name of medicine

Zavicefta

INN

ceftazidime / avibactam

Marketing-authorisation applicant

AstraZeneca AB

Therapeutic indication

Treatment 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 medicine

Zinbryta

INN

daclizumab

Marketing-authorisation applicant

Biogen Idec Ltd

Therapeutic indication

Treatment of relapsing forms of multiple sclerosis

More information

Summary of opinion for Zinbryta


Negative recommendation on new medicine

Name of medicine

Sialanar

INN

glycopyrronium bromide

Marketing-authorisation applicant

Proveca Limited

Therapeutic indication

Treatment of sialorrhoea

More information

Questions and answers on Sialanar


Positive recommendations on extensions of therapeutic indications


Name of medicine

Afinitor

INN

everolimus

Marketing-authorisation holder

Novartis Europharm Ltd

More information

Summary of opinion for Afinitor


Name of medicine

Avastin

INN

bevacizumab

Marketing-authorisation holder

Roche Registration Limited

More information

Summary of opinion for Avastin


Name of medicine

Ferriprox

INN

deferiprone

Marketing-authorisation holder

Apotex Europe BV

More information

Summary of opinion for Ferriprox


Name of medicine

Gazyvaro

INN

obinutuzumab

Marketing-authorisation holder

Roche Registration Limited

More information

Summary of opinion for Gazyvaro

Press release: New treatment for rare white blood cell cancer


Name of medicine

HyQvia

INN

human normal immunoglobulin

Marketing-authorisation holder

Baxalta Innovations GmbH

More information

Summary of opinion for HyQvia


Name of medicine

Imbruvica

INN

ibrutinib

Marketing-authorisation holder

Janssen-Cilag International NV

More information

Summary of opinion for Imbruvica


Name of medicine

Reyataz

INN

atazanavir / atazanavir sulfate

Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

More information

Summary of opinion for Reyataz


Name of medicine

Victoza

INN

liraglutide

Marketing-authorisation holder

Novo Nordisk A/S

More information

Summary of opinion for Victoza


Name of medicine

Zinforo

INN

ceftaroline fosamil

Marketing-authorisation holder

AstraZeneca AB

More information

Summary of opinion for Zinforo


Start of procedure

Name of medicine

Semler

More information

Start of a review on the conduct of studies at Semler Research Centre Private Ltd, Bangalore, India


Public health recommendation

Name of medicine

Inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

More information

EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease


Outcome of harmonisation procedure

Name of medicine

Novantrone and associated names

INN

mitoxantrone

Marketing-authorisation holder

MEDA group of companies and associated companies

More information

Questions 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


European Medicines Agency (EMA), 29.04.2016 (tB).

 
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