Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)

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21/09/2016

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)

Ten* medicines recommended for approval, including three medicines for cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval at its September meeting.

The CHMP recommended granting a conditional marketing authorisation for Lartruvo (olaratumab) for the treatment of adults with advanced soft tissue sarcoma. Lartruvo is to be used in combination with doxorubicin (a chemotherapy medicine) in patients with advanced soft tissue sarcoma for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin. Lartruvo was reviewed under EMA’s accelerated assessment mechanism and has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Ibrance (palbociclib) for the treatment of women with locally-advanced or metastatic breast cancer. Ibrance is to be used to treat breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)–negative. For more information, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Ninlaro (ixazomib) for the treatment of multiple myeloma. This follows a re-examination of the Committee’s earlier negative opinion. Ninlaro is a new medicine that is taken orally to treat multiple myeloma, and it has an orphan designation. Please see the questions-and-answers document in the grid below for more information on this opinion.

Glyxambi (empagliflozin / linagliptin) was recommended for approval for the treatment of type 2 diabetes.

Parsabiv (etelcalcetide) was recommended for approval for the treatment of secondary hyperparathyroidism.

One hybrid application, Chenodeoxycholic acid sigma-tau (chenodeoxycholic acid), received a positive opinion from the CHMP for the treatment of cerebrotendinous xanthomatosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. This medicine has an orphan designation.

Four generic medicines were recommended for approval by the Committee: Ivabradine JensenR (ivabradine) and Ivabradine Zentiva (ivabradine) to treat angina pectoris and heart failure, Emtricitabine / Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil) to treat HIV infection and Granpidam (sildenafil) for the treatment of patients with pulmonary arterial hypertension.

Two recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for NovoRapid and Stelara.

Outcome of review of compliance with good manufacturing practice (GMP) at Pharmaceutics International

The CHMP recommended that medicines manufactured by Pharmaceutics International Inc., located in the United States, should no longer be available in the European Union, except Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health. The recommendation is the outcome of a review into issues with GMP at Pharmaceutics International Inc. For more information, please see the public health communication in the grid below.

Withdrawals of applications

The application for a marketing authorisation for Cokiera (dasabuvir / ombitasvir / paritaprevir / ritonavir) has been withdrawn. Cokiera was intended for the treatment of chronic hepatitis C. A questions-and-answers document on this withdrawal is available below.

A request to extend the indication of Adempas (riociguat) to the treatment of pulmonary arterial hypertension associated with congenital heart disease has also been withdrawn. A questions-and-answers document on this withdrawal is available below.

Agenda and minutes

The agenda of the September 2016 meeting is published on EMA’s website. Minutes of the July 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the September 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s September 2016 meeting, is available in the grid below.


* The adoption of the CHMP opinion for SomaKit TOC was included in the CHMP highlights in error. This opinion has now been removed from the highlights as this procedure is still ongoing. Once the procedure is finalised, EMA will communicate its outcome. The below infographic has been updated to reflect this change.

CHMP_highlights_September_2016

Download image in PDF format


Positive recommendations on new medicines

Name of medicineGlyxambi
International non-proprietary name (INN)empagliflozin / linagliptin
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSummary of opinion for Glyxambi

 

Name of medicineIbrance
INNpalbociclib
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of locally advanced or metastatic breast cancer
More information

Summary of opinion for Ibrance
 

Press release: New treatment for breast cancer

  

Name of medicineLartruvo
INNolaratumab
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of soft tissue sarcoma
More information

Summary of opinion for Lartruvo
 

Press release: New treatment for patients with soft tissue sarcoma

 

Name of medicineNinlaro
INNixazomib
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of multiple myeloma
More information

Summary of opinion for Ninlaro
 

Questions and answers on the positive opinion on the marketing authorisation for Ninlaro

 

Name of medicineParsabiv
INNetelcalcetide
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of secondary hyperparathyroidism
More informationSummary of opinion for Parsabiv

 

Positive recommendations on new generic medicines

Name of medicineEmtricitabine/Tenofovir disoproxil Zentiva
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation applicantZentiva k.s.
Therapeutic indicationTreatment of HIV infection
More informationSummary of opinion for Emtricitabine/Tenofovir disoproxil Zentiva

  

Name of medicineGranpidam
INNsildenafil
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of pulmonary arterial hypertension
More informationSummary of opinion for Granpidam

 

Name of medicineIvabradine JensonR
INNivabradine
Marketing-authorisation applicantJensonR+Limited
Therapeutic indicationTreatment of angina pectoris and heart failure
More informationSummary of opinion for Ivabradine JensonR

 

Name of medicineIvabradine Zentiva
INNivabradine
Marketing-authorisation applicantZentiva, k.s.
Therapeutic indicationTreatment of angina pectoris and heart failure
More informationSummary of opinion for Ivabradine Zentiva

 

Positive recommendation on a new hybrid medicine

Name of medicineChenodeoxycholic acid sigma-tau
INNchenodeoxycholic acid
Marketing-authorisation applicantSigma-tau Arzneimittel GmbH
Therapeutic indicationTreatment of cerebrotendinous xanthomatosis
More informationSummary of opinion for Chenodeoxycholic acid sigma-tau

 

Positive recommendations on extensions of therapeutic indications

Name of medicineNovoRapid
INNinsulin aspart
Marketing-authorisation holderNovo Nordisk A/S
More informationSummary of opinion for NovoRapid

   

Name of medicineStelara
INNustekinumab
Marketing-authorisation holderJanssen-Cilag International NV
More informationSummary of opinion for Stelara

 

Public-health recommendation

Name of the procedurePharmaceutics International Inc
More informationPharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings

 

Outcome of harmonisation procedure

Name of medicineClenil and associated names
INNBeclometasone dipropionate
Marketing-authorisation holderChiesi and associated companies
More informationQuestions and answers on Clenil and associated names

 

Withdrawals of application

Name of medicineAdempas
INNriociguat
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Adempas

 

Name of medicineCokiera
INNdasabuvir / ombitasvir / paritaprevir / ritonavir
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Cokiera

 

Other opinion

Name of medicineAbilify
INNaripiprazole
More informationQuestions and answers on the application to extend use of Abilify in schizophrenia to 13 and 14 year olds

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Recommendations on eligibility to PRIME scheme
Opinions on safety variations
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Organisational matters

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