Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018

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29/06/2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018

Nine medicines recommended for approval, including the first two CAR-T cell therapies in the EU

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including six orphan medicines1, at its June 2018 meeting.

The CHMP recommended granting marketing authorisations for the first two chimeric antigen receptors (CAR) T-cell therapies in the European Union: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are both advanced therapy medicinal products (ATMPs) intended for the treatment of certain blood cancers. Kymriah and Yescarta were designated as orphan medicines during their development. They are also the first medicines supported through EMA’s PRIority MEdicines (PRIME) scheme to receive a positive opinion from the Committee.

Together with the approval recommendation for the first CAR-T cell therapies, the Committee also recommended an extension to the therapeutic indication for RoActemra (tocilizumab) to include the treatment of CAR-T-cell-induced cytokine release syndrome (CRS), a known serious side effect of CAR-T cell therapies. For more information on these medicines please see the press release in the grid below.

Four other orphan medicines were recommended for approval by the Committee: Cablivi (caplacizumab) for the treatment of acquired thrombotic thrombocytopenic purpura; Mepsevii (vestronidase alfa) for the treatment of mucopolysaccharidosis type VII; Veyvondi (vonicog alfa) for the treatment of von Willebrand disease and Vyxeos (daunorubicin / cytarabine) for the treatment of acute myeloid leukaemia.

Duzallo (lesinurad / allopurinol) received a positive opinion for the treatment of hyperuricaemia in patients with gout.

The CHMP granted a positive opinion for Ulipristal Acetate Gedeon Richter (ulipristal acetate), an informed consent application for the pre-operative treatment of uterine fibroids. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Positive recommendation on a new medicine following re-examination

The CHMP recommended granting a marketing authorisation for Nerlynx (neratinib), for the adjuvant treatment of adult patients with breast cancer, after re-examining its negative opinion for this medicine adopted in February 2018.

For more information on this positive opinion following re-examination, please see the question-and-answer document in the grid below.

Seven recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Dexdor, Inovelon, Jinarc, Lenvima, Opdivo, Rapamune and RoActemra (see above).

Start of referrals

The CHMP started a review of the effectiveness of bacterial lysate medicines in reducing the number and severity of respiratory infections in adults and children who experience repeated infections. For more information, please see the start-of-referral document in the grid below.

The Committee also started a review of Septanest (articaine / adrenaline solutions for injection) to harmonise the way the medicine is used in the countries where it is available. Septanest is a local anaesthetic used to prevent pain and discomfort in the mouth during dental procedures. For more information, please see the start-of-referral document in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for Graspa (L-asparaginase) was withdrawn by the company. This medicine was intended to be used for the treatment of acute lymphoblastic leukaemia. A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the June 2018 meeting is published on EMA’s website. Minutes of the May 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the June 2018 CHMP meeting are represented in the graphic below.


* The total number of negative opinions has been amended from six to five to reflect the positive opinion adopted by CHMP on Nerlynx following re-examination. Nerlynx initially received a negative opinion from the CHMP in February 2018.

More information on all other outcomes of the CHMP’s June 2018 meeting is available in the grid below.


1 As always at time of approval, these orphan designations will now be reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines’ orphan status and granting the medicines ten years of market exclusivity.


Positive recommendations on new medicines

Name of medicineCablivi
International non-proprietary name (INN)caplacizumab
Marketing-authorisation applicantAblynx NV 
Therapeutic indicationTreatment of acquired thrombotic thrombocytopenic purpura (aTTP)
More informationSummary of opinion for Cablivi

 

Name of medicineDuzallo 
INNlesinurad / allopurinol 
Marketing-authorisation applicantGrunenthal GmbH 
Therapeutic indicationTreatment of hyperuricaemia in gout patients
More informationSummary of opinion for Duzallo

  

Name of medicine Kymriah
INNtisagenlecleucel
Marketing-authorisation applicantNovartis Europharm Limited 
Therapeutic indicationTreatment of acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL)
More information

Summary of opinion for Kymriah
 

Press release: First two CAR-T cell medicines recommended for approval in the European Union

 

Name of medicine Mepsevii
INNvestronidase alfa
Marketing-authorisation applicantUltragenyx Germany GmbH 
Therapeutic indicationTreatment of mucopolysaccharidosis type VII
More informationSummary of opinion for Mepsevii

  

Name of medicineVeyvondi  
INNvonicog alfa
Marketing-authorisation applicantBaxalta Innovations GmbH 
Therapeutic indicationTreatment of von Willebrand disease
More informationSummary of opinion for Veyvondi

 

Name of medicineVyxeos
INNdaunorubicin / cytarabine
Marketing-authorisation applicantJazz Pharmaceuticals Ireland Limited 
Therapeutic indicationTreatment of acute myeloid leukaemia
More informationSummary of opinion for Vyxeos

 

Name of medicineYescarta  
INNaxicabtagene ciloleucel
Marketing-authorisation applicantKite Pharma EU B.V.
Therapeutic indicationTreatment of diffuse large cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL)
More information

Summary of opinion for Yescarta
 

Press release: First two CAR-T cell medicines recommended for approval in the European Union



Positive recommendation on new informed-consent application

Name of medicine Ulipristal Acetate Gedeon Richter
INNulipristal acetate
Marketing-authorisation applicantGedeon Richter Plc. 
Therapeutic indicationPre-operative treatment of uterine fibroids
More informationSummary of opinion for Ulipristal Acetate Gedeon Richter



Positive recommendation for new medicine following re-examination

Name of medicineNerlynx
INNneratinib
Marketing-authorisation holderPuma Biotechnology Limited
Therapeutic indicationAdjuvant treatment of adult patients with breast cancer
More information

Summary of opinion for Nerlynx
 

Questions and answers on the positive opinion on the marketing authorisation for Nerlynx - Outcome of re-examination



Positive recommendations on extensions of indications

Name of medicineDexdor
INNdexmedetomidine
Marketing-authorisation holderOrion Corporation 
More informationSummary of opinion for Dexdor

 

Name of medicineInovelon
INNrufinamide
Marketing-authorisation holderEisai Ltd. 
More informationSummary of opinion for Inovelon

 

Name of medicineJinarc
INNtolvaptan
Marketing-authorisation holderOtsuka Pharmaceutical Europe Ltd
More informationSummary of opinion for Jinarc

 

Name of medicineLenvima
INNlenvatinib
Marketing-authorisation holderEisai Europe Ltd. 
More informationSummary of opinion for Lenvima

  

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG 
More informationSummary of opinion for Opdivo

 

Name of medicineRapamune
INNsirolimus
Marketing-authorisation holderPfizer Limited 
More informationSummary of opinion for Rapamune

 

Name of medicineRoActemra
INNtocilizumab
Marketing-authorisation holderRoche Registration GmbH
More informationSummary of opinion for RoActemra



Withdrawal of initial application

Name of medicineGraspa
INNL-asparaginase
Marketing-authorisation applicantErytech Pharma S.A.
More informationQuestions and answers on withdrawal of the marketing authorisation application for Graspa



Start of referral

Name of medicineBacterial lysate medicines
More informationEMA reviewing bacterial lysate medicines for respiratory conditions 

 

Name of medicineSeptanest and associated names
INNarticaine / adrenaline
More informationEMA starts review of Septanest (articaine / adrenaline solutions for injection) and associated names 



Other updates

Recommendations on eligibility to PRIME scheme
Overview of (invented) names reviewed in May 2018 by the Name Review Group (NRG)
Start of community reviews
Scientific advice and protocol assistance

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