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Seven new medicines recommended for approval
EMA-Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013
London (April 26, 2013) – This page provides an overview of the opinions adopted at the April 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
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The Committee recommended the approval of the first combined tissue-engineered medicine to be authorised across the European Union (EU). MACI (matrix-induced autologous chondrocyte implantation) is an advanced-therapy medicinal product (ATMP) intended for the repair of cartilage defects.
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The Committee also gave a positive recommendation for the approval of Nuedexta, the first medicine for pseudobulbar effect approved in the EU.
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Four medicines to treat cancer received a positive opinion by the Committee: Erivedge, for the treatment of advanced basal cell carcinoma; Xtandi, for the treatment of prostate cancer and the two generic medicines Capecitabine Sun and Imatinib Accord.
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The CHMP also recommended that Spedra should be granted a marketing authorisation for the treatment of erectile dysfunction.
Negative opinion for Xeljanz
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The Committee adopted a negative opinion for Xeljanz for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis.
Two recommendations for extensions of indication
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The CHMP recommended an extension of the existing indication for Revlimid and also for RoActemra.
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CHMP confirms recommendation to restrict use of Protelos/Osseor
The Committee has recommended a restriction in the use of the osteoporosis medicine Protelos/Osseor, following an assessment of data showing an increased risk of serious heart problems.
Update on shortages
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The shortage of Caelyx, a medicine for the treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi’s sarcoma, has been resolved.
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A shortage of Increlex has been reported. This is a medicine used for the treatment of patients aged two to 18 years who are short for their age due to a condition known as ‘severe primary insulin-like-growth-factor-1 deficiency’; information on how to deal with the shortage will be sent to healthcare professionals in a direct healthcare professional communication (DHPC).
More information on these and all other outcomes of the CHMP April 2013 meeting is available in the table below.
Positive recommendations on new medicines
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Name of medicine |
Erivedge |
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International non-proprietary name (INN) |
vismodegib |
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Marketing-authorisation applicant |
Roche Registration Ltd |
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Therapeutic indication |
Treatment of advanced basal cell carcinoma |
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More information |
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Name of medicine |
MACI |
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Common name |
matrix applied characterised autologous cultured chondrocytes |
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Marketing-authorisation applicant |
Genzyme Europe B.V. |
|
Therapeutic indication |
Repair of symptomatic cartilage defects of the knee |
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More information |
|
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Name of medicine |
Nuedexta |
|
INN |
dextromethorphan hydrobromide, quinidine sulfate |
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Marketing-authorisation applicant |
Jenson Pharmaceutical Services Ltd |
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Therapeutic indication |
Treatment of pseudobulbar affect |
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More information |
|
Name of medicine |
Spedra |
|
INN |
avanafil |
|
Marketing-authorisation applicant |
VIVUS B.V. |
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Therapeutic indication |
Treatment of erectile dysfunction |
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More information |
|
Name of medicine |
Xtandi |
|
INN |
enzalutamide |
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Marketing-authorisation applicant |
Astellas Pharma Europe B.V. |
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Therapeutic indication |
Treatment of prostate cancer |
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More information |
Negative recommendations on new medicines
|
Name of medicine |
Xeljanz |
|
INN |
tofacitinib citrate |
|
Marketing-authorisation applicant |
Pfizer Ltd |
|
Therapeutic indication |
Treatment of moderate to severe active rheumatoid arthritis |
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More information |
Questions and answers on the refusal of the marketing authorisation for Xeljanz |
Positive recommendations on new generic medicines
|
Name of medicine |
Capecitabine Sun |
|
INN |
capecitabine |
|
Marketing-authorisation applicant |
Sun Pharmaceutical Industries Europe B.V. |
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Therapeutic indication |
Treatment of cancer |
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More information |
|
Name of medicine |
Imatinib Accord |
|
INN |
imatinib |
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Marketing-authorisation applicant |
Accord Healthcare Ltd |
|
Therapeutic indication |
Treatment of leukaemia |
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More information |
Positive recommendations on extensions of therapeutic indications
|
Name of medicine |
Revlimid |
|
INN |
lenalidomide |
|
Marketing-authorisation holder |
Celgene Europe Ltd |
|
Change to a therapeutic indication |
Multiple myeloma Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. |
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More information |
|
Name of medicine |
RoActemra |
|
INN |
tocilizumab |
|
Marketing-authorisation holder |
Roche Registration Ltd |
|
New therapeutic indication |
RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. |
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More information |
Recommendations for new contraindications
|
Name of medicine |
Pradaxa |
|
INN |
dabigatran etexilate |
|
Marketing-authorisation holder |
Boehringer Ingelheim International GmbH |
|
Change to a therapeutic indication |
Lesion or condition, if considereda significant risk factorfor major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. |
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More information |
|
Name of medicine |
Kinzalkomb |
|
INN |
telmisartan/hydrochlorothiazide |
|
Marketing-authorisation holder |
Bayer Pharma AG |
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New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2sup>) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
Kinzalmono |
|
INN |
telmisartan |
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Marketing-authorisation holder |
Bayer Pharma AG |
|
New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
Micardis |
|
INN |
telmisartan |
|
Marketing-authorisation holder |
Boehringer Ingelheim International GmbH |
|
New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
MicardisPlus |
|
INN |
telmisartan/hydrochlorothiazide |
|
Marketing-authorisation holder |
Boehringer Ingelheim International GmbH |
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New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
Onduarp |
|
INN |
telmisartan/amlodipine |
|
Marketing-authorisation holder |
Boehringer Ingelheim International GmbH |
|
New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
Pritor |
|
INN |
telmisartan |
|
Marketing-authorisation holder |
Bayer Pharma AG |
|
New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
PritorPlus |
|
INN |
telmisartan/hydrochlorothiazide |
|
Marketing-authorisation holder |
Bayer Pharma AG |
|
New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
|
Name of medicine |
Twynsta |
|
INN |
telmisartan/amlodipine |
|
Marketing-authorisation holder |
Boehringer Ingelheim International GmbH |
|
New contraindication |
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). |
|
More information |
Final opinions on other variations
|
Name of medicine |
Exjade |
|
INN |
deferasirox |
|
Marketing-authorisation holder |
Novartis Europharm Ltd |
|
More information |
Questions and answers on the outcome of extension of indication application for Exjade |
|
Name of medicine |
Menveo |
|
Common name |
meningococcal group A, C, W-135 and Y conjugate vaccine |
|
Marketing-authorisation holder |
Novartis Vaccines and Diagnostics S.r.l. |
|
More information |
Withdrawal of application
|
Name of medicine |
Raxone |
|
INN |
idebenone |
|
More information |
Supply shortages
|
Name of medicine |
Caelyx |
|
INN |
doxorubicin |
|
Marketing-authorisation holder |
Janssen-Cilag International N.V. |
|
More information |
|
Name of medicine |
Increlex |
|
INN |
mecasermin |
|
Marketing-authorisation holder |
Ipsen Pharma |
|
More information |
Public health communication
|
Recommendation to restrict the use of Protelos/Osseor (strontium ranelate) |
Other updates
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