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

News 19/10/2012

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 medicine	Amyvid
International non-proprietary name (INN)	florbetapir (¹⁸F)
Marketing-authorisation applicant	Eli Lilly Nederland BV
Therapeutic indication	Radiopharmaceutical 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 medicine	Betmiga
INN	mirabegron
Marketing-authorisation applicant	Astellas Pharma Europe BV
Therapeutic indication	Treatment of overactive bladder syndrome
More information	Summary of opinion for Betmiga

Name of medicine	Krystexxa
INN	pegloticase
Marketing-authorisation applicant	Savient Pharma Ireland Ltd
Therapeutic indication	Treatment of chronic gout
More information	Summary of opinion for Krystexxa

Name of medicine	Tresiba
INN	insulin degludec
Marketing-authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment 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 medicine	Ryzodeg
INN	insulin degludec / insulin aspart
Marketing-authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment of diabetes mellitus
More information	Summary of opinion for Ryzodeg

Negative recommendations on new medicines

Name of medicine	Acrescent
INN	memantine hydrochloride / donepezil hydrochloride
Marketing-authorisation applicant	H. Lundbeck A/S
Therapeutic indication	Treatment of Alzheimer's disease
More information	Questions and answers on Acrescent

Name of medicine	Balaxur
INN	memantine hydrochloride / donepezil hydrochloride
Marketing-authorisation applicant	Merz Pharmaceuticals GmbH
Therapeutic indication	Treatment of Alzheimer's disease
More information	Questions and answers on Balaxur

Name of medicine	Qsiva
INN	phentermine / topiramate
Marketing-authorisation applicant	Vivus BV
Therapeutic indication	Treatment of obesity
More information	Questions and answers on Qsiva

Positive recommendations on extensions of therapeutic indications

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	Abbott 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 information	Summary of opinion for Humira

Name of medicine	Isentress
INN	raltegravir
Marketing-authorisation holder	Merck 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 information	Summary of opinion for Isentress

Name of medicine	Thyrogen
INN	thyrotropin alfa
Marketing-authorisation holder	Genzyme 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 information	Summary of opinion for Thyrogen

Name of medicine	Xarelto
INN	rivaroxaban
Marketing-authorisation holder	Bayer 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 information	Summary of opinion for Xarelto

Positive recommendations on new generic medicines

Name of medicine	Imatinib Teva
INN	imatinib
Marketing-authorisation applicant	Teva Pharma BV
Therapeutic indication	Treatment of leukaemia
More information	Summary of opinion for Imatinib Teva