Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012

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19/10/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012

At the start of its October 2012 meeting, the Committee for Medicinal Products for Human Use (CHMP) elected Dr Ian Hudson as its new vice-chair for a three-year mandate.

Dr Hudson brings outstanding experience and expertise from a long career in regulatory medicine and drug development, particularly in the areas of anti-infectives and oncology. He currently holds the position of Director of the Licensing Division at the Medicines and Healthcare Products Regulatory Agency in London. Dr Hudson has been a member of the CHMP since 2004.

The opinions adopted by the CHMP at the October 2012 meeting and other important outcomes are listed in the table below.

The Agency publishes a new page following each month's CHMP meeting.

 

Positive recommendations on new medicines

Name of medicineAmyvid
International non-proprietary name (INN)florbetapir (18F)
Marketing-authorisation applicantEli Lilly Nederland BV
Therapeutic indicationRadiopharmaceutical indicated for positron-emission-tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment
More information

Summary of opinion for Amyvid

 

Press release: European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density


Name of medicineBetmiga
INNmirabegron
Marketing-authorisation applicantAstellas Pharma Europe BV
Therapeutic indicationTreatment of overactive bladder syndrome
More informationSummary of opinion for Betmiga


Name of medicineKrystexxa
INNpegloticase
Marketing-authorisation applicantSavient Pharma Ireland Ltd
Therapeutic indicationTreatment of chronic gout
More informationSummary of opinion for Krystexxa


Name of medicineTresiba
INNinsulin degludec
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of diabetes mellitus
More information

Summary of opinion for Tresiba

Press release: European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU


Name of medicineRyzodeg
INNinsulin degludec / insulin aspart
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of diabetes mellitus
More informationSummary of opinion for Ryzodeg

 

Negative recommendations on new medicines   

Name of medicineAcrescent
INNmemantine hydrochloride / donepezil hydrochloride
Marketing-authorisation applicantH. Lundbeck A/S
Therapeutic indicationTreatment of Alzheimer’s disease
More informationQuestions and answers on Acrescent


Name of medicineBalaxur
INNmemantine hydrochloride / donepezil hydrochloride
Marketing-authorisation applicantMerz Pharmaceuticals GmbH
Therapeutic indicationTreatment of Alzheimer’s disease
More informationQuestions and answers on Balaxur


Name of medicineQsiva
INNphentermine / topiramate
Marketing-authorisation applicantVivus BV
Therapeutic indicationTreatment of obesity
More informationQuestions and answers on Qsiva

 

Positive recommendations on extensions of therapeutic indications 

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbott Laboratories Ltd
New therapeutic indication

Paediatric Crohn's disease


Humira is indicated for the treatment of severe active Crohn's disease in paediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

More informationSummary of opinion for Humira

 

Name of medicineIsentress
INNraltegravir
Marketing-authorisation holderMerck Sharp & Dohme Ltd
Therapeutic indication
(changes in bold)
Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 2 years.
More informationSummary of opinion for Isentress

 

Name of medicineThyrogen
INNthyrotropin alfa
Marketing-authorisation holderGenzyme Europe BV
Therapeutic indication
(changes in bold)
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Low-risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.
Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).
More informationSummary of opinion for Thyrogen


Name of medicineXarelto
INNrivaroxaban
Marketing-authorisation holderBayer Pharma AG
Therapeutic indication
(changes in bold)

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.

Treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)

More informationSummary of opinion for Xarelto


 

Positive recommendations on new generic medicines

Name of medicineImatinib Teva
INNimatinib
Marketing-authorisation applicantTeva Pharma BV
Therapeutic indicationTreatment of leukaemia
More informationSummary of opinion for Imatinib Teva

 

Outcomes of arbitration procedures

Name of medicineINNMarketing-authorisation applicant
Furosemide VitabalansfurosemideVitabalans Oy
Levothyroxine AlapislevothyroxineAlapis SA

 


Re-examination of arbitration procedure

Name of medicineINNMarketing-authorisation applicant
LoraxinloratadineVitabalans Oy


Re-examination of safety review

Name of medicine
Tolperisone-containing medicines

 

Outcomes of Art.5(3) reviews

Press release: European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs

 

Questions and answers on the review of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk

Press release: European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy

 

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 October 2012 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