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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012
London (October 19, 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 & Healthcare Products Regulatory Agency in London. Dr Hudson has been a member of CHMP since 2004.
The opinions adopted by the CHMP at the October 2012 meeting and other important outcomes are listed in the table below.
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 |
|
Name of medicine |
Betmiga |
|
International non-proprietary name (INN) |
mirabegron |
|
Marketing-authorisation applicant |
Astellas Pharma Europe BV |
|
Therapeutic indication |
Treatment of overactive bladder syndrome |
|
More information |
|
Name of medicine |
Krystexxa |
|
International non-proprietary name (INN) |
pegloticase |
|
Marketing-authorisation applicant |
Savient Pharma Ireland Ltd |
|
Therapeutic indication |
Treatment of chronic gout |
|
More information |
|
Name of medicine |
Tresiba |
|
International non-proprietary name (INN) |
insulin degludec |
|
Marketing-authorisation applicant |
Novo Nordisk A/S |
|
Therapeutic indication |
Treatment of diabetes mellitus |
|
More information |
|
Name of medicine |
Ryzodeg |
|
International non-proprietary name (INN) |
insulin degludec / insulin aspart |
|
Marketing-authorisation applicant |
Novo Nordisk A/S |
|
Therapeutic indication |
Treatment of diabetes mellitus |
|
More information |
Negative recommendations on new medicines
|
Name of medicine |
Acrescent |
|
International non-proprietary name (INN) |
memantine hydrochloride / donepezil hydrochloride |
|
Marketing-authorisation applicant |
H. Lundbeck A/S |
|
Therapeutic indication |
Treatment of Alzheimer’s disease |
|
More information |
|
Name of medicine |
Balaxur |
|
International non-proprietary name (INN) |
memantine hydrochloride / donepezil hydrochloride |
|
Marketing-authorisation applicant |
Merz Pharmaceuticals GmbH |
|
Therapeutic indication |
Treatment of Alzheimer’s disease |
|
More information |
|
Name of medicine |
Qsiva |
|
International non-proprietary name (INN) |
phentermine / topiramate |
|
Marketing-authorisation applicant |
Vivus BV |
|
Therapeutic indication |
Treatment of obesity |
|
More information |
Positive recommendations on extensions of therapeutic indications
|
Name of medicine |
Humira |
|
International non-proprietary name (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 |
|
Name of medicine |
Isentress |
|
International non-proprietary name (INN) |
raltegravir |
|
Marketing-authorisation holder |
Merck Sharp & Dohme Ltd |
|
Therapeutic indication |
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 |
|
Name of medicine |
Thyrogen |
|
International non-proprietary name (INN) |
thyrotropin alfa |
|
Marketing-authorisation holder |
Genzyme Europe BV |
|
Therapeutic indication |
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). |
|
More information |
|
Name of medicine |
Xarelto |
|
International non-proprietary name (INN) |
rivaroxaban |
|
Marketing-authorisation holder |
Bayer Pharma AG |
|
Therapeutic indication |
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 |
Positive recommendations on new generic medicines
|
Name of medicine |
Imatinib Teva |
|
International non-proprietary name (INN) |
imatinib |
|
Marketing-authorisation applicant |
Teva Pharma BV |
|
Therapeutic indication |
Treatment of leukaemia |
|
More information |
Outcomes of arbitration procedures
|
Name of medicine |
INN |
Marketing authorisation applicant |
|
furosemide |
Vitabalans Oy |
|
|
levothyroxine |
Alapis SA |
Re-examination of arbitration procedure
|
Name of medicine |
INN |
Marketing authorisation applicant |
|
loratadine |
Vitabalans Oy |
Re-examination of safety review
|
Name of medicine |
Outcomes of Art.5(3) reviews
Other updates
|
European Medicines Agency, 19.10.2012 (tB).