Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016

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27/05/2016

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016

Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval

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

The CHMP recommended granting marketing authorisations in the European Union for two new combination therapies to treat chronic (long-term) hepatitis C, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir). For more information please see the press release in the grid below.

Qtern (saxagliptin / dapagliflozin) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus.

Three generic medicines received a positive opinion from the Committee: Bortezomib Hospira (bortezomib) and Bortezomib Sun (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma, and Pemetrexed Fresenius Kabi (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Ninlaro (ixazomib). Ninlaro was expected to be used for treating multiple myeloma in adults who had received at least one prior treatment. For more information, please see the questions-and-answers document in the grid below.

Request for re-examination of CHMP recommendation

The applicant for Sialanar (glycopyrronium bromide) has requested a re-examination of the CHMP’s negative opinion for this medicine adopted at the April 2016 meeting. The CHMP will now re-examine this opinion and issue a final opinion.

Six recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Adcetris, Humira, Kyprolis, Revestive, Simponi and Tysabri.

Withdrawals of applications

Applications for marketing authorisations for Xegafri (rociletinib) and Opsiria (sirolimus) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.

PRIME statistics

The first statistics on PRIME will be released on Wednesday 1 June, and then each month on the Wednesday following the CHMP meeting as part of the annexes in the CHMP highlights.

Agenda and minutes

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

CHMP statistics

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

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

CHMP_highlights_May_2016

Download image in PDF format

 

Positive recommendations on new medicines

Name of medicineEpclusa
INNsofosbuvir / velpatasvir
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of chronic hepatitis C
More information

Summary of opinion for Epclusa

 

Press release: Two new combination therapies against chronic hepatitis C

 

Name of medicineQtern
INNsaxagliptin / dapagliflozin
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSummary of opinion for Qtern

 

Name of medicineZepatier
INNelbasvir / grazoprevir
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of chronic hepatitis C
More information

Summary of opinion for Zepatier
 

Press release: Two new combination therapies against chronic hepatitis C

 

Negative recommendation on new medicine

Name of medicineNinlaro
INNixazomib
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of multiple myeloma
More informationQuestions and answers on refusal of the marketing authorisation for Ninlaro

 

Positive recommendations on new generic medicines

Name of medicineBortezomib Hospira
INNbortezomib
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationTreatment of multiple myeloma and mantle cell lymphoma
More informationSummary of opinion for Bortezomib Hospira

 

Name of medicineBortezomib Sun
INNbortezomib
Marketing-authorisation applicantSun Pharmaceutical Industries (Europe) B.V.
Therapeutic indicationTreatment of multiple myeloma and mantle cell lymphoma
More informationSummary of opinion for Bortezomib Sun

 

Name of medicinePemetrexed Fresenius Kabi
INNpemetrexed
Marketing-authorisation applicantFresenius Kabi Oncology PLC
Therapeutic indicationTreatment of unresectable malignant pleural mesothelioma and non-small cell lung cancer
More informationSummary of opinion for Pemetrexed Fresenius Kabi

 

Positive recommendations on extensions of therapeutic indications

Name of medicineAdcetris
INNbrentuximab vedotin
Marketing-authorisation holderTakeda Pharma A/S
More informationSummary of opinion for Adcetris

 

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbVie Ltd
More informationSummary of opinion for Humira

 

Name of medicineKyprolis
INNcarfilzomib
Marketing-authorisation holderAmgen Europe B.V.
More informationSummary of opinion for Kyprolis

  

Name of medicineRevestive
INNteduglutide
Marketing-authorisation holderNPS Pharma Holdings Limited
More informationSummary of opinion for Revestive

 

Name of medicineSimponi
INNgolimumab
Marketing-authorisation holderJanssen Biologics B.V.
More informationSummary of opinion for Simponi

   

Name of medicineTysabri
INNnatalizumab
Marketing-authorisation holderBiogen Idec Ltd
More informationSummary of opinion for Tysabri

  

Outcome of arbitration procedure

Name of medicineLevonelle 1500mcg tablets and associated names
INNlevonorgestrel
Marketing-authorisation holderGedeon Richter Plcv Group of companies
More informationLevonelle 1500 microgram tablets and associated names

 

Withdrawals of initial marketing authorisation applications

Name of medicineOpsiria
INNsirolimus
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Opsiria

 

Name of medicineXegafri
INNrociletinib
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Xegafri

 

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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