Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 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 medicine	Erivedge
International non-proprietary name (INN)	vismodegib
Marketing-authorisation applicant	Roche Registration Ltd
Therapeutic indication	Treatment of advanced basal-cell carcinoma
More information	CHMP summary of positive opinion for Erivedge

Name of medicine	Maci
Common name	matrix applied characterised autologous cultured chondrocytes
Marketing-authorisation applicant	Genzyme Europe B.V.
Therapeutic indication	Repair of symptomatic cartilage defects of the knee
More information	CHMP summary of positive opinion for Maci Press release: European Medicines Agency recommends approval of combined advanced-therapy product

Name of medicine	Nuedexta
INN	dextromethorphan hydrobromide / quinidine sulfate
Marketing-authorisation applicant	Jenson Pharmaceutical Services Ltd
Therapeutic indication	Treatment of pseudobulbar affect
More information	CHMP summary of positive opinion for Nuedexta Press release: European Medicines Agency recommends approval of first treatment for pseudobulbar affect

Name of medicine	Spedra
INN	avanafil
Marketing-authorisation applicant	Vivus B.V.
Therapeutic indication	Treatment of erectile dysfunction
More information	CHMP summary of positive opinion for Spedra

Name of medicine	Xtandi
INN	enzalutamide
Marketing-authorisation applicant	Astellas Pharma Europe B.V.
Therapeutic indication	Treatment of prostate cancer
More information	CHMP summary of positive opinion for Xtandi

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
More information	Questions and answers on 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.
Therapeutic indication	Treatment of cancer
More information	CHMP summary of positive opinion for Capecitabine SUN

Name of medicine	Imatinib Accord
INN	imatinib
Marketing-authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of leukaemia
More information	CHMP summary of positive opinion for Imatinib Accord

Positive recommendations on extensions of therapeutic indications

Name of medicine	Revlimid
INN	lenalidomide
Marketing-authorisation holder	Celgene 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	CHMP post-authorisation summary of positive opinion for Revlimid

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 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	CHMP post-authorisation summary of positive opinion for RoActemra

Recommendations for new contraindications

Name of medicine	Pradaxa
INN	dabigatran etexilate
Marketing-authorisation holder	Boehringer 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	CHMP post-authorisation summary of positive opinion for Pradaxa

Name of medicine	Kinzalkomb
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 m²sup>) (see sections 4.2, 4.4, 4.5).
More information	CHMP post-authorisation summary of positive opinion for Kinzalkomb

Name of medicine	Kinzalmono
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	CHMP post-authorisation summary of positive opinion for Kinzalmono

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	CHMP post-authorisation summary of positive opinion for Micardis

Name of medicine	MicardisPlus
INN	telmisartan / hydrochlorothiazide
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	CHMP post-authorisation summary of positive opinion for MicardisPlus

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	CHMP post-authorisation summary of positive opinion for Onduarp

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	CHMP post-authorisation summary of positive opinion for Pritor

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	CHMP post-authorisation summary of positive opinion for PritorPlus

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	CHMP post-authorisation summary of positive opinion for Twynsta

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	Questions and answers on the outcome of application to extend use of Menveo in children less than two years

Withdrawal of application