Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014

This page provides an overview of the opinions adopted at the February 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Ten new medicines recommended for approval

The CHMP has recommended granting a paediatric-use marketing authorisation (PUMA) for Hemangiol (propranolol) for the treatment of proliferating infantile haemangioma. This is the second time that the Committee has granted a positive opinion for a PUMA since the introduction of this type of marketing authorisation by the Paediatric Regulation, which came into force in 2007. Please see the press release in the grid below for more information.

This month, a number of medicines for the treatment of chronic obstructive pulmonary disease (COPD) were recommended for marketing authorisation by the CHMP.

The Committee recommended granting marketing authorisations for six medicines for the treatment of respiratory diseases. Four of these, Anoro (umeclidinium bromide / vilanterol) and Laventair (umeclidinium bromide / vilanterol), as well as Incruse (umeclidinium bromide) and Ulunar Breezhaler (indacaterol / glycopyrronium bromide), are intended for the treatment of symptoms in adult patients with COPD. The remaining two, DuoResp Spiromax (budesonide / formoterol) and BiResp Spiromax (budesonide / formoterol), are intended for the treatment of asthma and COPD.

In other therapeutic areas, Vimizim (elosulfase alfa) was granted marketing authorisation by the CHMP for the treatment of mucopolysaccharidosis type IVA. Vimizim has an orphan designation.

The Committee recommended the granting of a marketing authorisation for Vokanamet (canagliflozin / metformin) for the treatment of type 2 diabetes.

Pregabalin Pfizer (pregabalin) was also recommended for approval by the Committee for the treatment of neuropathic pain, epilepsy and general anxiety disorder.

New compassionate-use programme

The CHMP has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use programme. Please see the press release in the grid below for more information.

Outcome of two safety reviews

The CHMP has recommended restricting the use of methysergide-containing medicines due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body's organs potentially damaging them.

The CHMP concluded its review of Protelos/Osseor at its February meeting and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis. For more information, please see the public health communication below.

Four requests for re-examination of CHMP recommendations

The marketing authorisation holders for Masiviera, Nerventra, Reasanz and Translarna have requested re-examinations of the CHMP's negative opinions for these medicines adopted during the January 2014 meeting. Upon receipt of the grounds of the requests for re-examination, the CHMP will re-examine these opinions and issue final opinions.

Withdrawal of application

A questions-and-answers document on the withdrawal of marketing authorisation application for Heplisav is also published below.

More information on these and other outcomes of this month's meeting are available in the table below.

CHMP welcomes new member

At the February 2014 CHMP, Dimitrios Kouvelas replaced Aikaterini Moraiti as the new CHMP member for Greece.

Agenda and minutes

The agenda of the February 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the March CHMP meeting. Minutes of the January 2014 CHMP meeting will be published next week.

CHMP statistics

Key figures from the February 2014 CHMP meeting are represented in the graphic below.

Positive recommendations on new medicines

Name of medicine	Anoro
International non-proprietary name (INN)	umeclidinium bromide / vilanterol
Marketing-authorisation applicant	Glaxo Group Ltd
Therapeutic indication	Treatment of symptoms in adult patients with chronic obstructive pulmonary disease
More information	CHMP summary of positive opinion for Anoro

Name of medicine	Hemangiol
INN	propranolol
Marketing-authorisation applicant	Pierre Fabre Dermatologie
Therapeutic indication	Treatment of proliferating infantile haemangioma
More information	CHMP summary of positive opinion for Hemangiol
	Press release: European Medicines Agency gives second positive opinion for a paediatric-use marketing authorisation

Name of medicine	Incruse
INN	umeclidinium bromide
Marketing-authorisation applicant	Glaxo Group Ltd
Therapeutic indication	Treatment of symptoms in adult patients with chronic obstructive pulmonary disease
More information	CHMP summary of positive opinion for Incruse

Name of medicine	Laventair
INN	umeclidinium bromide / vilanterol
Marketing-authorisation applicant	Glaxo Group Ltd
Therapeutic indication	Treatment of symptoms in adult patients with chronic obstructive pulmonary disease
More information	CHMP summary of positive opinion for Laventair

Name of medicine	Vimizim
INN	elosulfase alfa
Marketing-authorisation applicant	BioMarin Europe Ltd
Therapeutic indication	Treatment of mucopolysaccharidosis, type IVA
More information	CHMP summary of positive opinion for Vimizim

Name of medicine	Vokanamet
INN	canagliflozin / metformin
Marketing-authorisation applicant	Janssen-Cilag International N.V.
Therapeutic indication	Treatment of type 2 diabetes mellitus
More information	CHMP summary of positive opinion for Vokanamet

Positive recommendation on new informed-consent application

Name of medicine	Pregabalin Pfizer
INN	pregabalin
Marketing-authorisation applicant	Pfizer Limited
Therapeutic indication	Treatment of of neuropathic pain, epilepsy and generalised anxiety disorder
More information	CHMP summary of positive opinion for Pregabalin Pfizer

Name of medicine	Ulunar Breezhaler
INN	indacaterol / glycopyrronium bromide
Marketing-authorisation applicant	Novartis Europharm Ltd
Therapeutic indication	Treatment of chronic obstructive pulmonary disease
More information	CHMP summary of positive opinion for Ulunar Breezhaler

Positive recommendations on new hybrid medicines

Name of medicine	BiResp Spiromax
INN	budesonide / formoterol
Marketing-authorisation applicant	Teva Pharma B.V.
Therapeutic indication	Treatment of asthma and chronic obstructive pulmonary disease
More information	CHMP summary of positive opinion for BiResp Spiromax

Name of medicine	DuoResp Spiromax
INN	budesonide / formoterol
Marketing-authorisation applicant	Teva Pharma B.V.
Therapeutic indication	Treatment of asthma and chronic obstructive pulmonary disease
More information	CHMP summary of positive opinion for DuoResp Spiromax

Compassionate use

Name of medicine	Sofosbuvir / Ledipasvir
INN	sofosbuvir / ledipasvir
Applicant	Gilead Sciences
More information	Press release: European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C

Public-health recommendations

Name of medicine	Methysergide-containing products
INN	methysergide
Marketing-authorisation holder	Amdipharm Mercury and Alliance Pharmaceuticals
More information	Methysergide-containing products

Name of medicine	Protelos and Osseor
INN	strontium ranelate
Marketing-authorisation holder	Les Laboratoires Servier
More information	Protelos and Osseor

Withdrawals of application

Name of medicine	Firazyr
INN	icatibant
Marketing-authorisation holder	Shire Orphan Therapies GmbH
More information	Firazyr: Withdrawn extension application

Name of medicine	Heplisav
Common name	Hepatitis B (rDNA) vaccine (adjuvanted)
Marketing-authorisation holder	Dynavax International B.V.
More information	Heplisav: Withdrawn application