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 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

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	CHMP 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	CHMP 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	CHMP 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	CHMP summary of positive opinion for Ongentys

Name of medicine	Umbipro
INN	chlorhexidine
Marketing-authorisation applicant	GlaxoSmithKline Trading Services
Therapeutic indication	Prophylaxis of omphalitis
More information	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	CHMP 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	CHMP 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 refusal of the marketing authorisation for Sialanar (glycopyrronium bromide)

Positive recommendations on extensions of therapeutic indications

Name of medicine	Afinitor
INN	everolimus
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Afinitor

Name of medicine	Avastin
INN	bevacizumab
Marketing-authorisation holder	Roche Registration Limited
More information	CHMP post-authorisation summary of positive opinion for Avastin

Name of medicine	Ferriprox
INN	deferiprone
Marketing-authorisation holder	Apotex Europe BV
More information	CHMP post-authorisation summary of positive opinion for Ferriprox

Name of medicine	Gazyvaro
INN	obinutuzumab
Marketing-authorisation holder	Roche Registration Limited
More information	CHMP post-authorisation summary of positive opinion for Gazyvaro Press release: New treatment for rare white blood cell cancer

Name of medicine

Gazyvaro

INN

obinutuzumab

Marketing-authorisation holder

Roche Registration Limited

More information

CHMP post-authorisation summary of positive 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	CHMP post-authorisation summary of positive opinion for HyQvia

Name of medicine	Imbruvica
INN	ibrutinib
Marketing-authorisation holder	Janssen-Cilag International NV
More information	CHMP post-authorisation summary of positive opinion for Imbruvica

Name of medicine	Reyataz
INN	atazanavir / atazanavir sulfate
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	CHMP post-authorisation summary of positive opinion for Reyataz

Name of medicine	Victoza
INN	liraglutide
Marketing-authorisation holder	Novo Nordisk A/S
More information	CHMP post-authorisation summary of positive opinion for Victoza

Name of medicine	Zinforo
INN	ceftaroline fosamil
Marketing-authorisation holder	AstraZeneca AB
More information	CHMP post-authorisation summary of positive 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)