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

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21/02/2014

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.

 

CHMP highlights February 2104

 

Positive recommendations on new medicines

Name of medicineAnoro
International non-proprietary name (INN)umeclidinium bromide / vilanterol
Marketing-authorisation applicantGlaxo Group Ltd
Therapeutic indicationTreatment of symptoms in adult patients with chronic obstructive pulmonary disease
More informationSummary of opinion for Anoro

   

Name of medicineHemangiol
INNpropranolol
Marketing-authorisation applicantPierre Fabre Dermatologie
Therapeutic indicationTreatment of proliferating infantile haemangioma
More informationSummary of opinion for Hemangiol
 Press release: European Medicines Agency gives second positive opinion for a paediatric-use marketing authorisation

 

Name of medicineIncruse
INNumeclidinium bromide
Marketing-authorisation applicantGlaxo Group Ltd
Therapeutic indicationTreatment of symptoms in adult patients with chronic obstructive pulmonary disease
More informationSummary of opinion for Incruse

 

Name of medicineLaventair
INNumeclidinium bromide / vilanterol
Marketing-authorisation applicantGlaxo Group Ltd
Therapeutic indicationTreatment of symptoms in adult patients with chronic obstructive pulmonary disease
More informationSummary of opinion for Laventair

 

Name of medicineVimizim
INNelosulfase alfa
Marketing-authorisation applicantBioMarin Europe Ltd
Therapeutic indicationTreatment of mucopolysaccharidosis, type IVA
More informationSummary of opinion for Vimizim

 

Name of medicineVokanamet
INNcanagliflozin / metformin
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSummary of opinion for Vokanamet

 

Positive recommendation on new informed-consent application

Name of medicinePregabalin Pfizer
INNpregabalin
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of of neuropathic pain, epilepsy and generalised anxiety disorder
More informationSummary of opinion for Pregabalin Pfizer

 

Name of medicineUlunar Breezhaler
INNindacaterol / glycopyrronium bromide
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of chronic obstructive pulmonary disease
More informationSummary of opinion for Ulunar Breezhaler

 

Positive recommendations on new hybrid medicines

Name of medicineBiResp Spiromax
INNbudesonide / formoterol
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationTreatment of asthma and chronic obstructive pulmonary disease
More informationSummary of opinion for BiResp Spiromax

 

Name of medicineDuoResp Spiromax
INNbudesonide / formoterol
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationTreatment of asthma and chronic obstructive pulmonary disease
More informationSummary of opinion for DuoResp Spiromax

 

Compassionate use

Name of medicineSofosbuvir / Ledipasvir
INNsofosbuvir / ledipasvir
ApplicantGilead Sciences
More informationPress release: European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C

 

Public-health recommendations

Name of medicineMethysergide-containing products
INNmethysergide
Marketing-authorisation holderAmdipharm Mercury and Alliance Pharmaceuticals
More informationMethysergide-containing products

 

Name of medicineProtelos and Osseor
INNstrontium ranelate
Marketing-authorisation holderLes Laboratoires Servier
More informationProtelos and Osseor

 

Withdrawals of application

Name of medicineFirazyr
INNicatibant
Marketing-authorisation holderShire Orphan Therapies GmbH
More informationFirazyr: Withdrawn extension application

 

Name of medicineHeplisav
Common nameHepatitis B (rDNA) vaccine (adjuvanted)
Marketing-authorisation holderDynavax International B.V.
More informationHeplisav: Withdrawn application

 

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 January 2014 by the Name Review Group (NRG)
Organisational matters

 

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 7418 8427
E-mail: press@ema.europa.eu