Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013

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26/07/2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013

This page provides an overview of the opinions adopted at the July 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

At its July meeting, the CHMP welcomed Ivana Mikacic as the Croatian member of the Committee following the accession of Croatia to the European Union on 1 July 2013. Ana Dugonjic has been appointed as the Croatian alternate. This addition brings the total number of CHMP members to 33.

Eight new medicines recommended for approval

The CHMP recommended the approval of Giotrif for the treatment of lung cancer.

The CHMP also recommended that Incresync, Vipdomet and Vipidia should be granted marketing authorisations for the treatment of type-2 diabetes.

Ultibro Breezhaler and Xoterna Breezhaler received positive opinions from the Committee for the treatment of chronic obstructive pulmonary disease (COPD).

The Committee recommended that Tybost should be granted a marketing authorisation for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in combination with the protease inhibitors atazanavir and darunavir.

The Committee also gave a positive recommendation for the approval of Grastofil, a biosimilar medicine for the treatment of neutropenia.

Negative opinion for Delamanid

The Committee adopted a negative opinion for Delamanid, which was intended for the treatment of multi-drug-resistant tuberculosis.

Seven recommendations on extensions of therapeutic indications

The CHMP recommended extensions to the existing indications for Eylea, Ilaris, Prezista, Revolade, Simponi, Stelara and Zonegran.

Re-examination of two initial recommendations for marketing authorisation

The CHMP adopted a positive re-examination opinion for Defitelio, for the treatment of severe hepatic veno-occlusive disease (VOD) in patients undergoing blood-stem-cell transplantation.

It also adopted a final negative opinion following the re-examination of Xeljanz which was intended for the treatment of moderate to severe active rheumatoid arthritis.

Investigation on GLP-1 based diabetes therapies concluded

The CHMP has finalised a review of glucagon-like-peptide-1 (GLP-1)-based diabetes therapies. The Committee concluded that available data do not confirm recent concerns over an increased pancreatic cancer risk with these medicines. For more information, please see the press release in the grid below.

Outcome of two further safety reviews

In addition to the safety review on GLP-1-based diabetes therapies, the Committee also issued recommendations on ketoconazole-containing medicines for oral use and metoclopramide-containing medicines.

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

 

Positive recommendations on new medicines

Name of medicineGiotrif
International non-proprietary name (INN)afatinib
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationTreatment of epidermal-growth-factor-receptor (EGFR) tyrosine-kinase-inhibitor-naïve adult patients with locally advanced or metastatic non-small-cell lung cancer with activating EGFR mutations
More informationSummary of opinion for Giotrif

 

Name of medicineGrastofil
International non-proprietary name (INN)filgrastim
Marketing-authorisation applicantApotex Europe BV
Therapeutic indicationTreatment of neutropenia
More informationSummary of opinion for Grastofil

 

Name of medicineIncresync
INNalogliptin / pioglitazone
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of type-2 diabetes mellitus
More informationSummary of opinion for Incresync

 

Name of medicineTybost
INNcobicistat
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in HIV-1-infected adults
More informationSummary of opinion for Tybost

 

Name of medicineUltibro Breezhaler
INNglycopyrronium bromide / indacaterol
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of COPD
More informationSummary of opinion for Ultibro Breezhaler

 

Name of medicineVipdomet
INNalogliptin / metformin
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of type-2 diabetes mellitus
More informationSummary of opinion for Vipdomet

 

Name of medicineVipidia
INNalogliptin
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of type-2 diabetes mellitus
More informationSummary of opinion for Vipidia

 

Name of medicineXoterna Breezhaler
INNglycopyrronium bromide / indacaterol
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of COPD
More informationSummary of opinion for Xoterna Breezhaler

    

Negative recommendation on new medicine

Name of medicineDelamanid
INNdelamanid
Marketing-authorisation applicantOtsuka Novel Products GmbH
Therapeutic indicationTreatment of multi-drug-resistant tuberculosis
More informationQuestions and answers on the refusal of the marketing authorisation for Delamanid

 

Re-examinations of initial recommendations for marketing authorisation

Name of medicineDefitelio
INNdefibrotide
Marketing-authorisation applicantGentium S.p.A.
Therapeutic indicationTreatment of severe VOD in patients undergoing blood-stem-cell transplantation
More information

Summary of opinion for Defitelio


Questions and answers on the positive opinion on the marketing authorisation for Defitelio

  

Name of medicineXeljanz
INNtofacitinib
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of moderate to severe active rheumatoid arthritis
More informationQuestions and answers on the refusal of the marketing authorisation for Xeljanz

 

Positive recommendations on extensions of therapeutic indications  

Name of medicineEylea
INNaflibercept
Marketing-authorisation holderBayer Pharma AG
Change to the indication
(changes in bold)
Eylea is indicated for adults for the treatment of:
- neovascular (wet) age-related macular degeneration (see section 5.1);
- visual impairment due to macular oedema secondary to central-retinal-vein occlusion (see section 5.1).
More informationSummary of opinion for Eylea

 

Name of medicineIlaris
INNcanakinumab
Marketing-authorisation holderNovartis Europharm Ltd.
Change to the indication
(changes in bold)
 
Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes in adults, adolescents and children aged two years and older with body weight of 7.5 kg or above, including:
- Muckle-Wells syndrome (MWS);
- neonatal-onset multisystem inflammatory disease / chronic infantile neurological, cutaneous, articular syndrome;
- severe forms of familial cold auto-inflammatory syndrome / familial cold urticaria presenting with signs and symptoms beyond cold-induced urticarial skin rash
- Ilaris is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients aged two years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.
More informationSummary of opinion for Ilaris

  

Name of medicinePrezista
INNdarunavir
Marketing-authorisation holderJanssen-Cilag International N.V.
Change to the indication
(changes in bold)
Prezista 400- and 800-mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 12 years and at least 40 kg body weight who are:
-
antiretroviral-therapy (ART)-naïve (see section 4.2);
- ART-experienced with no darunavir-resistance-associated mutations and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with Prezista in such ART-experienced patients, genotypic testing should guide the use of Prezista (see sections 4.2, 4.3, 4.4 and 5.1).
More informationSummary of opinion for Prezista

 

Name of medicineRevolade
INNeltrombopag
Marketing-authorisation holderGlaxoSmithKline Trading Services
Change to the indication
(changes in bold)
- Revolade is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade may be considered as second-line treatment for adult non-splenectomised patients where surgery is contraindicated.
- Revolade is indicated in adult patients with chronic hepatitis-C-virus infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.
More informationSummary of opinion for Revolade

 

Name of medicineSimponi
INNgolimumab
Marketing-authorisation holderJanssen Biologics B.V.
Change to the indication
(changes in bold)

Rheumatoid arthritis (RA)

Simponi, in combination with methotrexate (MTX), is indicated for:
- the treatment of moderate to severe, active RA in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate;
- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.

Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

Psoriatic arthritis (PsA)

Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.

Ankylosing spondylitis (AS)

Simponi is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy.

Ulcerative colitis (UC)

Simponi is indicated for treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6‑mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

More informationSummary of opinion for Simponi

 

Name of medicineStelara
INNustekinumab
Marketing-authorisation holderJanssen-Cilag International N.V.
Change to the indication
(changes in bold)

Plaque psoriasis

Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX and psoralen ultraviolet A (see section 5.1).

PsA

Stelara, alone or in combination with MTX, is indicated for the treatment of active PsA in adult patients when the response to previous non-biological DMARD therapy has been inadequate (see section 5.1).

More informationSummary of opinion for Stelara

 

Name of medicineZonegran
INNzonisamide
Marketing-authorisation holderEisai Ltd
Extension of indication
(changes in bold)
Zonegran is indicated as:
- monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
- adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.
More informationSummary of opinion for Zonegran

 

Recommendation on other variations

Name of medicineInsuman
INNinsulin human
Marketing-authorisation holderSanofi-aventis Deutschland GmbH
More informationSummary of opinion for Insuman

 

Withdrawal of applications

Name of medicineEffentora
INNfentanyl citrate
More informationEffentora: Withdrawn application

 

Name of medicineEviplera
INNemtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate
More informationEviplera: Withdrawn application

  

Outcome of arbitration procedure

Name of medicineMethylphenidate Hexal
INNmethylphenidate hydrochloride  
Marketing-authorisation holderHexal A/S
More informationMethylphenidate Hexal: Article-29 referral

 

Name of medicineMethylphenidate Sandoz
INNmethylphenidate hydrochloride  
Marketing-authorisation holderSandoz A/S
More informationMethylphenidate Sandoz: Article-29 referral

 

Opinion on any scientific matter (Article 5(3))

Name of medicineGLP-1 based therapies
INNexenatide, liraglutide, lixisenatide, sitagliptin, saxagliptin, vildagliptin, linagliptin
More informationInvestigation into GLP-1-based diabetes therapies concluded

 

Public-health communications on non-centrally authorised medicines

Name of medicineKetoconazole-containing medicines for oral use
INNketoconazole
More informationKetoconazole-containing medicines: Article-31 referral

 

European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole

 

Name of medicineMetoclopramide-containing medicines
INNmetoclopramide
More informationMetoclopramide-containing medicines: Article-31 referral

 

European Medicines Agency recommends changes to the use of metoclopramide

 

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 July 2013 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

 

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