Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013
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Human
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 |
| 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
| Name of medicine | Raxone |
|---|---|
| INN | idebenone |
| More information | Raxone: Withdrawn application |
Supply shortages
| Name of medicine | Caelyx |
|---|---|
| INN | doxorubicin |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | Questions and answers on the supply situation of Caelyx |
| Name of medicine | Increlex |
|---|---|
| INN | mecasermin |
| Marketing-authorisation holder | Ipsen Pharma |
| More information | Questions and answers on the shortage of Increlex |
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