Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 2013

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20/12/2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 2013

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

Publication of CHMP agendas and minutes

The CHMP agenda was published for the first time during the December 2013 meeting. The minutes of the December 2013 CHMP meeting will be published in January 2014. It will then be standard practice to publish the CHMP agenda at the start of each meeting and the minutes after their adoption the following month. For more information, see the press release published earlier this week.

The agenda of the CHMP undergoes continuous changes as the meeting progresses; this means, for example, that although a medicine is marked in the agenda as due for opinion, the Committee may decide to postpone adoption of its opinion if deemed necessary. All outcomes of the CHMP meeting will be included in the meeting minutes.

Five medicines recommended for approval

The CHMP has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adults when an effective treatment regime cannot otherwise be composed for reasons of resistance or tolerability. Sirturo has an orphan designation. See the press release in the grid below for more details.

The CHMP recommended the granting of a conditional marketing authorisation for Cometriq (cabozantinib) for the treatment of medullary thyroid carcinoma. Cometriq has an orphan designation.

The Committee gave a positive recommendation for Izba (travoprost) for the treatment of ocular hypertension and open-angle glaucoma.

The Committee also recommended the granting of a marketing authorisation for Mirvaso (brimonidine) for the treatment of facial erythema of rosacea in adults.

The Committee recommended the granting of a marketing authorisation for Neuraceq (florbetaben (18F)) for the detection of beta-amyloid in the brain in patients being evaluated for Alzheimer’s disease and other causes of cognitive impairment.

Positive scientific opinion on Tritanrix HB (Article 58)

The CHMP adopted a positive scientific opinionin accordance with Article 58 of Regulation (EC) No 726/2004 for Tritanrix HB for immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards. Article 58 establishes a mechanism whereby the European Medicines Agency (EMA) can give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of medicines for human use that are intended exclusively for markets outside the European Union (EU). Medicines eligible for this procedure are used to prevent or treat diseases of major public health interest. Tritanrix HB is no longer used in the EU and its EU marketing authorisation will cease to be valid at the end of 2013. The request was submitted to the EMA by the applicant under Article 58 in order to avoid an interruption in the availability of the vaccine outside the EU, where it is still used in several countries.

Negative opinion on Winfuran

The Committee adopted a negative opinion for Winfuran (nalfurafine), an orphan medicine which was intended for the treatment of uraemic pruritus in patients with end-stage kidney disease on dialysis.

Recommendation on extension of therapeutic indication

The CHMP recommended an extension of indication for Jentadueto.

Outcome of two safety reviews

The CHMP issued recommendations on Estradiol (topical use) and Kogenate / Helixate NexGen.

Re-examination of Masican

The applicant for Masican has requested a re-examination of the CHMP’s November 2013 negative opinion. Upon receipt of the grounds for the request, the CHMP will re-examine its opinion and issue a final recommendation.

Withdrawal of application for extension of therapeutic indication

A question-and-answer document on the withdrawal of an application for extension of indication for Exelon/ Prometax is also published below.

More information on these and other outcomes of this month’s meeting are available in the table below. All other outcomes of the December CHMP meeting will be included in the meeting minutes to be published in January 2014.

Positive recommendations on new medicines

Name of medicineCometriq
International non-proprietary name (INN)cabozantinib
Marketing-authorisation applicantTMC Pharma Services Ltd
Therapeutic indicationTreatment of medullary thyroid carcinoma
More informationSummary of opinion for Cometriq

  

Name of medicineIzba
INNtravoprost
Marketing-authorisation applicantAlcon Laboratories (UK) Ltd
Therapeutic indicationTreatment of ocular hypertension and open-angle glaucoma
More informationSummary of opinion for Izba

 

Name of medicineMirvaso
INNbrimonidine
Marketing-authorisation applicantGalderma International
Therapeutic indicationTreatment of facial erythema of rosacea in adult patients
More informationSummary of opinion for Mirvaso

 

Name of medicineNeuraceq
INNflorbetaben (18F)
Marketing-authorisation applicantPiramal Imaging GmbH
Therapeutic indicationDetection of β-amyloid in the brain
More informationSummary of opinion for Neuraceq

 

Name of medicineSirturo
INNbedaquiline
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of pulmonary tuberculosis
More informationSummary of opinion for Sirturo

European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis

 

Name of medicineTritanrix HB
Common namediphtheria (d), tetanus (t), pertussis (whole cell) (pw) and hepatitis B (rdna) (hbv) vaccine (adsorbed)
Marketing-authorisation applicantGlaxoSmithKline Biologicals S.A.
Therapeutic indicationActive immunisation against diphtheria, tetanus, pertussis and hepatitis B
More informationSummary of opinion for Tritanrix HB - submitted under Article 58 for use outside the European Union

 

Negative recommendation on new medicine

Name of medicineWinfuran
INNnalfurafine
Marketing-authorisation applicantToray International U.K. Limited
Therapeutic indicationTreatment of uraemic pruritus
More informationQuestions and answers on refusal of the marketing authorisation for Winfuran

 

Positive recommendation on extension of therapeutic indication

Name of medicineJentadueto
INNlinagliptin / metformin
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More informationSummary of opinion for Jentadueto

    

Withdrawal of application for extension of therapeutic indication

Name of medicineExelon / Prometax
INNrivastigmine
Marketing-authorisation holderNovartis Europharm Ltd
More informationQuestions and answers on the withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax

 

Public-health recommendations

Name of medicineEstradiol (topical use)
INNestradiol
More informationEstradiol

 

Name of medicineHelixate NexGen / Kogenate Bayer
INNoctocog alfa
More informationHelixate NexGen / Kogenate Bayer

 

 Outcomes of arbitration procedures

Name of medicineNanotop
INNhuman albumin, denatured [NanoHSA]
More informationNanotop

 

Name of medicineTibolona Aristo / Tibocina
INNtibolone
More informationTibolona Aristo / Tibocina

 

Name of medicineValebo
INNalendronic acid and alfacalcidol
More informationValebo

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations / periodic safety update reports’
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in November 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