Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013

News 26/04/2013

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.

Seven new medicines recommended for approval

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.

The Committee also gave a positive recommendation for the approval of Nuedexta, the first medicine for pseudobulbar affect approved in the EU.

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.

The CHMP also recommended that Spedra should be granted a marketing authorisation for the treatment of erectile dysfunction.

Negative opinion for Xeljanz

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

The CHMP recommended an extension of the existing indication for Revlimid and also for RoActemra.

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

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.

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

Name of medicineErivedge
International non-proprietary name (INN)vismodegib
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of advanced basal-cell carcinoma
More information PDF iconSummary of opinion for Erivedge

Name of medicineMaci
Common namematrix applied characterised autologous cultured chondrocytes
Marketing-authorisation applicantGenzyme Europe B.V.
Therapeutic indicationRepair of symptomatic cartilage defects of the knee
More information

PDF iconSummary of opinion for Maci


Press release: European Medicines Agency recommends approval of combined advanced-therapy product

Name of medicineNuedexta
INNdextromethorphan hydrobromide / quinidine sulfate
Marketing-authorisation applicantJenson Pharmaceutical Services Ltd
Therapeutic indicationTreatment of pseudobulbar affect
More information

PDF iconSummary of opinion for Nuedexta


Press release: European Medicines Agency recommends approval of first treatment for pseudobulbar affect

Name of medicineSpedra
INNavanafil
Marketing-authorisation applicantVivus B.V.
Therapeutic indicationTreatment of erectile dysfunction
More information PDF iconSummary of opinion for Spedra

Name of medicineXtandi
INNenzalutamide
Marketing-authorisation applicantAstellas Pharma Europe B.V.
Therapeutic indicationTreatment of prostate cancer
More information PDF iconSummary of opinion for Xtandi

Negative recommendations on new medicines

Name of medicineXeljanz
INNtofacitinib citrate
Marketing-authorisation applicantPfizer Ltd
Therapeutic indicationTreatment of moderate to severe active rheumatoid arthritis
More information PDF iconQuestions and answers on the refusal of the marketing authorisation for Xeljanz

Positive recommendations on new generic medicines

Name of medicineCapecitabine Sun
INNcapecitabine
Marketing-authorisation applicantSun Pharmaceutical Industries Europe B.V.
Therapeutic indicationTreatment of cancer
More information PDF iconSummary of opinion for Capecitabine Sun

Name of medicineImatinib Accord
INNimatinib
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of leukaemia
More information PDF iconSummary of opinion for Imatinib Accord



Positive recommendations on extensions of therapeutic indications

Name of medicineRevlimid
INNlenalidomide
Marketing-authorisation holderCelgene Europe Ltd
Change to a therapeutic indication
(changes in bold)

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.


Myelodysplastic syndromes


Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

More information PDF iconSummary of opinion for Revlimid

Name of medicineRoActemra
INNtocilizumab
Marketing-authorisation holderRoche Registration Ltd
New therapeutic indicationRoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (rheumatoid-factor-positive or -negative and extended oligoarthritis) in patients two 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.
More information PDF iconSummary of opinion for RoActemra



Recommendations for new contraindications

Name of medicinePradaxa
INNdabigatran etexilate
Marketing-authorisation holderBoehringer Ingelheim International GmbH
Change to contraindication
(changes in bold)
Lesion or condition, if considered a significant risk factor for 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.
More information PDF iconSummary of opinon for Pradaxa

Name of medicineKinzalkomb
INNtelmisartan / hydrochlorothiazide
Marketing-authorisation holderBayer Pharma AG
New contraindicationThe 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 PDF iconSummary of opinon for Kinzalkomb

Name of medicineKinzalmono
INNtelmisartan
Marketing-authorisation holderBayer Pharma AG
New contraindicationThe 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 PDF iconSummary of opinon for Kinzalmono

Name of medicineMicardis
INNtelmisartan
Marketing-authorisation holderBoehringer Ingelheim International GmbH
New contraindicationThe 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 PDF iconSummary of opinon for Micardis

Name of medicineMicardisPlus
INNtelmisartan / hydrochlorothiazide
Marketing-authorisation holderBoehringer Ingelheim International GmbH
New contraindicationThe 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 PDF iconSummary of opinon for MicardisPlus

Name of medicineOnduarp
INNtelmisartan / amlodipine
Marketing-authorisation holderBoehringer Ingelheim International GmbH
New contraindicationThe 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 PDF iconSummary of opinon for Onduarp

Name of medicinePritor
INNtelmisartan
Marketing-authorisation holderBayer 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 PDF iconSummary of opinon for Pritor

Name of medicinePritorPlus
INNtelmisartan / hydrochlorothiazide
Marketing-authorisation holderBayer Pharma AG
New contraindicationThe 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 PDF iconSummary of opinon for PritorPlus

Name of medicineTwynsta
INNtelmisartan / amlodipine
Marketing-authorisation holderBoehringer Ingelheim International GmbH
New contraindicationThe 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 PDF iconSummary of opinon for Twynsta



Final opinions on other variations

Name of medicineExjade
INNdeferasirox
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconQuestions and answers on the outcome of extension of indication application for Exjade

Name of medicineMenveo
Common namemeningococcal group A, C, W-135 and Y conjugate vaccine
Marketing-authorisation holderNovartis Vaccines and Diagnostics S.r.l.
More information PDF iconQuestions and answers on outcome of application to extend use of Menveo in children less than two years



Withdrawal of application

Name of medicineRaxone
INNidebenone
More informationRaxone: Withdrawn application



Supply shortages

Name of medicineCaelyx
INNdoxorubicin
Marketing-authorisation holderJanssen-Cilag International N.V.
More information PDF iconQuestions and answers on the supply situation of Caelyx


Name of medicineIncrelex
INNmecasermin
Marketing-authorisation holderIpsen Pharma
More information PDF iconQuestions and answers on the shortage of Increlex



Public health communication

Recommendation to restrict the use of Protelos / Osseor (strontium ranelate)


Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
Start of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in March 2013 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

How useful was this page?

Add your rating