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. 

  • 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 effect 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

Summary of 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

Summary of 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

Summary of 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

Summary of 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

Summary of 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 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.

Therapeutic indication

Treatment of cancer

More information

Summary of opinion for Capecitabine Sun

  

Name of medicine

Imatinib Accord

INN

imatinib

Marketing-authorisation applicant

Accord Healthcare Ltd

Therapeutic indication

Treatment of leukaemia

More information

Summary of 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

Summary of 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 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.

More information

Summary of opinion for RoActemra

 

 

Recommendations for new contraindications

 

Name of medicine

Pradaxa

INN

dabigatran etexilate

Marketing-authorisation holder

Boehringer Ingelheim International GmbH

Change to a therapeutic indication
(changes in bold)

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.

More information

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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

Summary of opinon 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 outcome of application to extend use of Menveo in children less than 2 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

 

 

Public health communication

 

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


Other updates

 

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Opinions on safety variations
  • Start of Community reviews
  • Guidelines and concept papers adopted
  • Organisational matters
  • Opinions on consultation procedures on ancillary medicinal substances in medical devices

 

 


European Medicines Agency, 26.04.2013 (tB).

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